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Opportunities

Assembler, Saxonburg, PA

POSITION DUTIES & RESPONSIBILITIES

  • Assembling various products
  • Packaging various products
  • Performing rework and inspection on the product
  • Backing up higher-level positions
  • Awareness of quality standards and ability to identify defects in products
  • Recording data related to product quality and traceability
  • Cleaning of work areas as required
  • Complete the associated paperwork

 

REQUIREMENTS/PREFERENCES

  • High School Diploma or GED equivalent
  • 1 year of work experience
  • Entry level math skills (adding/subtracting)
  • Basic reading skills
  • Good hand-eye coordination and attention to detail
  • Communication skills
  • Able to adapt quickly to fast-paced changing situations
  • Proven sound judgment, continuous improvement, and customer focus
  • Demonstrated adaptability and teamwork skills

 

Preferences (Experience, Skills):

  • 3-6 months Assembly experience
  • Experience in medical device manufacturing experience
  • Knowledge of computer application

 

To apply for this position, send your resume to [email protected]

CNC Programmer, Freeport, PA

SUMMARY:

Under limited supervision, converts scientific, engineering and other technical problem formulations to format procedures by computer by performing the following duties.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Confers with other engineers and technical personnel to resolve problems of intent, inaccuracy or feasibility of CNC machines.
  • Reviews results of CNC machine runs with interested personnel to determine necessity for modifications or returns.
  • Design special tooling.
  • Generate print-outs for details that are sent to the shop.
  • Develops new subroutines or expands programs to simplify statement, programming or coding of future problems.
  • Maintain a clean and orderly work area.
  • Comply with state and federal law safety regulations in addition to company safety and security procedures.
  • Adhere to company policies and state and federal laws and regulations relating to employment, including promoting a workplace free of discrimination and harassment
  • Other related duties as assigned.

 

PHYSICAL DEMANDS:

  • While performing the duties of this job, the employee is required to sit at a computer terminal for extended periods of time and occasionally travel between departments.

 

WORK ENVIRONMENT:

  • While performing the duties of this job, the employee will regularly have to travel through other departments.  The atmosphere is a climatic office setting, and the employee will spend the majority of his/her time sitting at a computer terminal.

 

 

QUALIFICATIONS:

  • Must have a working knowledge of machining practices.
  • Must be able to read and understand blueprints.
  • Under normal business conditions, must be able to work 50 hours per week, however, schedule will be adjusted according to business and operational needs.
  • Must possess knowledge of algebra, geometry, and trigonometry.
  • Must be able to organize work and prioritize tasks.
  • Must be able to understand written correspondence.
  • Must be able to communicate through written, verbal, or other means of communication.
  • Must be able to wear personal protection equipment, such as earplugs, safety glasses, and safety shoes.
  • Must have the ability and interpersonal skills to successfully work as a team member to obtain desired results.
  • Must be able to understand and apply work-related documents such as operating manuals, maintenance instructions, and procedure manuals.
  • Must be able to understand and perform to job-related quality standards, methods, usage of inspection devices and reporting as required.
  • Must be able to travel domestically and internationally.
  • Must be a U.S. citizen or be able to comply with S. export regulations.

 

PREVIOUS EXPERIENCE/EDUCATIONAL QUALIFICATIONS:

  • High school diploma or equivalent.
  • 5 Years tool room or machine programming experience required.
  • 2 Years CAD/CAM experience preferred.

 

To apply for this position, send your resume to [email protected]

CNC Specialist, Freeport, PA

SUMMARY:

Under minimal supervision, maintain the high standards associated with the company and produce accurate high quality tool steeled parts to support the companies die manufactory.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Set up and operate equipment to efficiently perform job.
  • Must be able to hold tolerances within .0001”.
  • Must read, understand and program CNC machines.
  • Work with other departments on special projects.
  • Make parts and fixtures for other departments.
  • Produce acceptable number of parts in established time frames.
  • Inspect parts and record results.
  • Perform routine maintenance checks on machines.
  • Offer input on how to improve operations.
  • Understands use of cutters and possesses the ability to determine correct feeds and speeds.
  • Adheres to verification system guidelines.
  • Assist in training of other employees.
  • Must be able to program and make adjustments to machines.
  • Must be able to contour precise profiles to inspection charts.
  • Maintain a clean and orderly work area.
  • Comply with state and federal law safety regulations in addition to company safety and security procedures.
  • Adhere to company policies and state and federal laws and regulations relating to employment, including promoting a workplace free of discrimination and harassment.
  • Other related duties as assigned.

 

PHYSICAL DEMANDS:

  • While performing the duties of this job, the employee is regularly required to work in a standing, sitting, or bent position for 10 hours/day and must be able to lift a minimum of 25 pounds with control.
  • The employee must be able to raise arms above shoulders and maintain dexterity for extended periods of time and also use hands to handle or feel objects, tools, or controls; reach with hands and arms; and be able to stoop or kneel for excessive periods of time.
  • The employee must be able to perform the physical demands of the job with or without reasonable accommodation.
  • The employee must be able to wear personal protective equipment.

 

WORK ENVIRONMENT:

  • While performing the duties of this job, the employee is frequently around large industrial machinery, and the employee constantly works near moving mechanical parts that create a moderately high noise level.

 

QUALIFICATIONS:

  • Must be able to read and understand blueprints.
  • Must be able to identify, diagnose and provide a solution to problems.
  • Under normal business conditions, must be able to work 50 hours per week, however, schedule will be adjusted according to business and operational needs.
  • Must possess knowledge of algebra, geometry, and trigonometry.
  • Must be able to train other employees as required.
  • Must be able to communicate through written, verbal, or other means of communication.
  • Must be able to wear personal protection equipment, such as earplugs, safety glasses, and safety shoes.
  • Must have the ability and interpersonal skills to successfully work as a team member to obtain desired results.
  • Must be able to understand and apply work-related documents such as operating manuals, maintenance instructions, and procedure manuals.
  • Must be able to understand and perform to job-related quality standards, methods, usage of inspection devices and reporting as required.
  • Must be able to travel domestically and internationally.
  • Must be a U.S. citizen or be able to comply with S. export regulations.

 

PREVIOUS EXPERIENCE/EDUCATIONAL QUALIFICATIONS:

  • High school diploma or equivalent.
  • Successful completion of the apprenticeship program or equivalent experience required.
  • 4 Years CNC experience preferred.

 

To apply for this position, send your resume to [email protected]

Lab Technician, Cleveland, TN

POSITION/TITLE: Laboratory Technician

DEPARTMENT/TEAM DESCRIPTION
FDA regulated, QC analytical chemistry laboratory that is responsible for testing of raw materials, intermediates, finished products, and stability samples of over-the-counter healthcare products.

POSITION SUMMARY
Entry level job that performs routine laboratory analysis of raw materials, intermediates, finished products, and/or stability samples following established procedures in a FDA regulated, QC analytical chemistry laboratory. This position primarily utilizes wet bench chemistry techniques and basic instrumentation.

This position has a high potential to rotate between 1st and 2nd shift. Training will be conducted on 1st shift (8:00am – 4:30pm) for approximately 3-4 months. Then, the analyst will either be assigned to a 1st shift team (7:00am – 3:30pm) or a 2nd shift team (3:00pm – 11:30pm).

This position has a high potential to work seasonal overtime. Employee must work well with all laboratory personnel in a team environment, as well as colleagues in other sections of Quality Operations and the site. Employee must have a Safety mindset and must adhere the organization’s LIFE values of Leadership, Integrity, Flexibility, and Efficiency.

POSITION DUTIES & RESPONSIBILITIES

Testing of raw materials.
Testing of finished products for release and stability.
Preparation of standards and solutions.
Follows standard operating procedures.
Daily equipment verifications.
Maintains ongoing training requirements.
Participates in and supports continuous improvement projects.

REQUIREMENTS/PREFERENCES
Education Requirement(s):
Preferred Bachelor’s Degree in Chemistry or related field

Skill & Competency Requirements:
Effective computer skills
Effective communication skills
Effective writing skills

Business Systems Analyst, Alexandria, VA

As a Business Systems Analyst, you will be responsible for communicating with customers to capture system requirements, perform system verification, and assist in the troubleshooting of production support issues for an Agile Big Data team.

 

Day to day responsibilities include:

Liaison between customers and development team.

Provide requirements and design clarifications for development team.

Verify application development, including querying data stores with SQL.

Provide application overviews and demos to stakeholders.

Create and maintain system documentation.

Excellent written and verbal communication skills

Strong attention to detail

 

Skills and Experience

5+ years’ experience in application development/full life cycle or Database systems engagement

Experience participating on an Agile Scrum team, including: sprint planning, daily scrum, sprint reviews and retrospectives, backlog grooming, and release planning.

Familiarity with the following concepts: Application Logs, Data Visualization, Data Enrichment, Web Services/Microservices, Configuration Management, Relational Databases, Unix/Linux OS, physical, virtual and cloud based infrastructure.

Familiarity with the following technologies:

Hadoop eco system, including HDFS, YARN, Cassandra, Hive, Pig, and Spark

Batch-oriented and streaming distributed processing methods such as Spark, Kafka, or Storm

Distributed NoSQL/Key-Value stores such as HBase, Accumulo, Cassandra, or DynamoDB

Distributed search engines like Elasticsearch or Solr

Bachelor’s Degree in Information Technology, Computer Science or a related field is required.

This is a direct hire position with a great company based in Alexandria, VA.  Salary is $130,000- $150,000 plus great benefits package! Please send resumes to, [email protected]

Software Implementation Specialist, Columbia, MD

Software Implementation Specialist

Position summary

Configures, implements, and demonstrates System Automation’s software products to administrators and end-users. The implementation cycle includes requirements validation, internal testing, and guiding clients through user-acceptance to go-live status.

 

Key Responsibilities

Configures and implements all MyLicense products with minimal supervision

Trains users on MyLicense software

Analyzes both the system’s and user’s requirements / needs and acts in a troubleshooter capacity

Participates in gathering requirements, specifications, and provides input during enhancement reviews

Interfaces and deals with clients via email and phone, providing top-notch customer service

 

Knowledge, Skills and Abilities

Ability to debug simple network issues

Demonstrated ability to communicate technical information to non-technical professionals

Desired: knowledge of SQL server database or other relational database structures

Desired: familiarity with data conversion

Desired: working knowledge of HTML, CSS, JavaScript

Excellent interpersonal skills

Demonstrated effective public speaking and/or presentation skills

Excellent verbal communication and feedback skills: Ability to give full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times

Demonstrated analytical, troubleshooting, and problem-solving skills

Demonstrated ability of providing superlative customer service

Ability to act as a champion for a corporate culture of product and customer satisfaction

Professional, positive and enthusiastic attitude

Ability to work alone or in groups with some direction

Ability to manage multiple tasks for multiple projects

 

 

Ability to perform quality work within deadlines

Ability to travel 75% of the time

 

Qualifications

High-school diploma

At least two years’ experience in a technical role

Experience with configuration of proprietary software

General Manager, Cary, NC

Recruits, leads and develops people to execute outstanding QSC &V, build sales and control costs to deliver optimum business results for a single fast food restaurant. Key customers include Crew, Restaurant Leadership Assistant team, and customers.

Principal responsibilities:

Demonstrates and reinforces the leadership behaviors and basic people minimums (uniforms, crew schedules, rap sessions, etc.) necessary to gain commitment from crew and leadership.

Executes a plan, based on an employee commitment measurement, to increase employee’s loyalty, satisfaction and pride with the MacDonald’s experience.

Knows, enforces and educates crew and managers on all appropriate personnel policies, labor laws, security and safety procedures.

Recruits, selects and retains an optimum number of crew, maintenance, and management who are enthusiastically dedicated to customer satisfaction.

Leads the development and training of all restaurant employees.

Oversees and reviews performance appraisals based on defined goals and objectives for all restaurant employees in a timely manner.

Plans and conducts leadership team meetings.

Maintains critical standards for raw and finished product quality, service speed and quality, cleanliness and sanitation.

Models performance standards for all crew stations and maintenance as needed.

Measures external customer’s satisfaction and executes plan to improve their satisfaction with their McDonald’s experience and increase their loyalty.

Effectively schedules to build the business on all day parts.

Effectively executes national and co-op promotions to maximize sales potential.

Effectively develops and executes my store (local store) marketing plans to maximize sales potential within the community.

Conducts in-restaurant implementation of new products and procedures.

Enforces and manages all food safety and sanitation requirements and practices.

Ensures all security procedures are executed (cash deposits, staggered method of open/close etc.)

Maintains all physical plants aspects of the restaurant, including landscaping, building, equipment, etc.

Accurately projects and controls P&L line items, e.g food, labor, etc.

Administers in-restaurant employee benefits and payroll procedures, including reporting to national and regional offices.

Uses proper security and verification procedures when handling deposits and the contents of the safe.

Maintains records for safety and appropriately documents contributions and performance in personnel files.

Ensures that all daily paperwork, weekly inventories and statistical reports are completed accurately and on a timely basis.

Education:

High school diploma.

SEO Project Manager - Morristown, NJ

DEPARTMENT/TEAM DESCRIPTION: IT Operations Marketing & Sales Execute team is responsible for support, minor enhancements, monitoring and optimization for all applications/systems within Marketing & Sales landscape across all divisions.

POSITION SUMMARY: We are seeking an experienced SEO Web Project Manager (PM) Technical Quality Assurance (QA) Analyst to join our IT Operations team focused on development, support, maintenance, and monitoring of marketing websites. The right candidate will possess demonstrable experience performing comprehensive website audits (technical, content, & links) with a focus on quality and identifying improvement opportunities from an SEO perspective.

This position requires a deep knowledge of technical SEO best practices with a focus on translating site audits into optimization action plans to ensure compliance across company properties. You must be comfortable reviewing a site’s architecture, and understand how search engines will crawl the site, what practices to avoid, and what on-page changes will have the most impact based on current algorithms. Candidate will function as the key connection point between SEO Agency Partners who conduct audits and provide recommendations and the technical production partner who will implement the recommendations. The focus of PM will be to translate the recommendations into action plans and the QA role will be to review implementation to ensure proper application and SEO effectiveness.

POSITION DUTIES:
Design and execute test plans based on the documentation provided by the development team
Ability to perform comprehensive website audits (technical, content & links) for new and existing websites
Provide technical analysis of website performance and outline areas of opportunities to improve from an SEO perspective with a focus on crawlability, site architecture and site content
Function as a key connection point between SEO Agency Partner (SEO Recommendations) and the IT Production Partner to develop, deliver and manage implementation action plans
Work alongside marketing brand teams and development team to ensure all technical, content and social signals are being developed to help boost organic results
Communicate quality and user experience concerns objectively to the development team
Setup and monitoring of Google/Bing Webmaster Tools to identify crawling and indexing issues for remediation
Monitor client sites regularly for technical crawl issues and other relevant errors (outdated links, 404s, incorrect redirects, etc.) using a variety of SEO tools and expertise
Ensure that appropriate SEO standards are closely adhered to and develop and manage quality checklists to ensure proper implantation to ensure optimal indexation of all company properties
Stay up to date on current industry practices, news and algorithm updates and provide continuous education to ensure compliance across sites
Apply, and be able to explain, SEO best practices for site navigation, breadcrumbing, internal links (including anchor text optimization), and HTML sitemaps to client websites
Apply, and be able to explain, SEO best practices for domain, sub-domain and directory structure to client websites
Communicate complex SEO strategies to a wide range of stakeholders
Measure the success of SEO campaigns with use of web analytics and SEO campaign management tools  Develop SEO Best Practice play books to ensure IT Production Partners are clear on the practices that need to be managed in the development of new digital pages/properties

REQUIREMENTS/PREFERENCES:
The ideal candidate for this position should be able to (or possess):

2+ years of experience in digital testing role with hands on experience testing responsive websites on mobile and tablet devices
2+ year of relatable experience in managing complex projects with a track record of delivering on time and on budget
4+ years of relevant SEO experience
Experience with web application load and performance testing and techniques
Ability to identify critical or complex areas in the system and test accordingly
Expertise in functional testing – regression testing and ad-hoc testing
An in-depth understanding of search engine behavior: what content search engines crawl and read, what practices to avoid, and what on-page changes will have the most impact based on current algorithms
Basic SQL knowledge – able to connect to, understand schema and query databases
Basic knowledge of web development

Experience using SEO campaign management software (such as BrightEdge, SEMRush, Moz)
Up-to-date understanding of organic search trends, including search engine algorithm changes, the latest tools and technologies
Experience with automated web application testing tools and techniques
Experience with defect tracking tools, such as JIRA
Ability to thrive in a fast-paced work environment, with multiple project releases per week
Possess an extremely high attention to detail and quality
Excellent presentation, communication, analytical and problem-solving skills
Desire to collaborate with others in a team environment
Experience with Mobile Test Automation (e.g. Perfecto Mobile, Appium) a big plus
Experience with SiteCore and Teamsite CMS editing a big plus

Clinical Trial Specialist, Whippany, NJ

POSITION SUMMARY
The Clinical Trial Specialist contributes to the organization’s drive for business quality and efficiency by being responsible for facilitating and providing efficient study support and expertise to the global study management teams. The CS study and project coordination activities are accomplished because of a strong skillset, understanding of clinical science operations and global operating processes of drug development within the complex boundaries of an early phase study

CS Clinical Trial Specialist (CTS) collaborates with the OPLs, Study Managers, Study Teams, CRO’s, and other key stake-holders for the global trial initiation conduct and reporting of trial progress by coordinating and performing assigned development and operational activities. The CTS is instrumental in enabling Global Clinical Program and Study Management in achieving efficiency, compliance, quality as well as project/study milestones in both internally managed and outsourced complex clinical projects and trials. The CTS is expected to directly liaise with OPL and StM (and ECL as applicable), and play an active role in operational oversight, logistical planning, project and study status monitoring, corrective action planning, systems support and study communications. Provide overall operational technical support and expertise for managing programs and studies.

POSITION DUTIES & RESPONSIBILITIES
These global studies are conducted within the standards set by Global Development, according to Good Clinical Practices (GCP) and applicable regulatory and legal requirements and include the key operational responsibilities for CTS:

Maintain global operational tracking and reporting systems and tools including but not limited to he study/project budget and financial management data), YourDOCeS (invoices), IMPACT (updates for planned/concept studies), ShareDoc PhlexGlobal (eTMF documents), Quality Risk Indicator systems, eFilia (contracts), Study drug destruction trackers etc. Develop study specific tracking systems if applicable.

Provide detailed support for cost tracking (study budgets, project budgets and special events. Exercise clear decision making on invoice reconciliations based on knowledge of the protocol, patient visit design, lab draw timings and other study specific parameters that require understanding of the therapeutic area specifics and study conduct.

Provide technical and administrative support and expertise for contract tracking by acting as a main point of contact for contract handling and by liaising globally with internal and external partners to facilitate progress and identify potential issues.

Assist with oversight of study metrics, compliance with systems use and present/report issues, progress, and status at global meetings via written and verbal communication (if applicable).

Assist and collaborate in development of project / study related documents. Support Clinical Study Report preparation (e.g. appendices) if applicable

Coordinate project / study material preparation and global study communication internally and/or with vendors:
Consistent and collaborative communication to internal (CSM, cPharm, GCS –ECL, OPL, STM, CLM, CRA, etc.) and external partner (CRO, Laboratory, etc.)
Create and send communications materials to countries and/or study sites (e.g. Newsletters, updates, etc.)
Support the maintenance and construction of study specific internet based forums, such as study websites, SharePoints, Investigator Portal, etc.
Coordinate communication of project/study status to various levels of management

Provide meeting coordination for the global clinical and study team members (StM, OPL, cPharms) in scheduling, agenda, presentations, arrangements, minutes, and action item tracking including global and regional investigator meetings, global/regional monitor training meetings (if applicable) and advisory committee meetings as requested by ECL/OPL.

Responsible for setting up, maintaining on ongoing basis, providing expertise in quality controlling and archiving of the global Trial Master File (TMF) (paper TMF or eTMF) – including but not limited to Study Files. Provide technical knowledge of the “essential documents” as described in the SOPs and required by the global regulatory authorities (FDA, SFDA, PMDA, MOH EMA, etc.). Provide proactive, close support to Study Manager with quality control and verification of the TMF managed/maintained by external suppliers. Participate and support audits (Regulatory Authorities and QA), inspections and verification of TMF. Ensure the quality, completeness, availability and quality of the clinical study documents in the Trial Master File to enable final compilation of the documents for regulatory submissions and approval of new medications and medical devices.

Provide expertise in non-project activities
Provide technical expertise for the eTMF.
Provide consultative guidance on new systems, processes and procedures (e.g. SharePoint, inspection readiness, etc.)
May represent GCP&SM Support Service in areas of various initiatives (e.g. as representative or leader of the expert working groups,)
Actively suggest means to increase efficiency and other improvement measures
Provide technical expertise of the budget and payment systems (YOUR-DoceS, for assistance with forecasts, actual cost updates, etc.)
Provide expertise with the use of SOP repository (QDoc and others as necessary)
Support to functional Heads of ECL&OPLs in presentations, organizing trips, equipment ordering, and other general tasks

REQUIREMENTS/PREFERENCES:
Education Requirement(s):
The incumbent must have an associate’s degree (or equivalent) and 5-7 years of clinical research/development experience or a bachelor’s degree (or equivalent) with 2 – 3 years of experience in clinical research/development in the pharmaceutical industry.

Skill & Competency Requirements:
The incumbent must have the ability to manage multiple high level parallel tasks; work unsupervised, have effective computer skills, possess the ability to apply new techniques, and strong prioritization skills.
Must display effective planning and organizational skills, innovativeness, and keen attention to detail and excellent follow through.
The incumbent must have strong interpersonal skills in working with highly qualified teams, 3rd parties and people in a global environment.
Excellent written and oral communication skills

Preferences:
SharePoint

Chemist, Myerstown, PA

POSITION SUMMARY
Perform the analysis on in-process, finished products, stability products following prescribed procedures to provide the information base leading to raw product disposition. Assist in troubleshooting and problem solving as directed.

POSITION DUTIES & RESPONSIBILITIES
Perform standard qualitative and quantitative analysis on: in-process products, and finished pharmaceutical preparations employing accepted gravimetric and spectrophotometer procedures, in accordance with approved testing procedures of the National Formulary (NF) and the United States Pharmacopoeia (USP).
Utilize standard “bench” chemistry technique as well as sophisticated electronic instrumentation, including spectrophotometer, viscometer, etc.
Maintain records of all analysis information of assigned products on data sheets for permanent file and proper entry of information on laboratory forms.
Evaluate all data obtained from analysis; if discrepancy or deviation occurs, consult with Supervisor and recommend additional testing if necessary.
Perform routine analytical testing of raw materials purchased from prospective suppliers to determine that the materials meet compendia and/or company standards.
Adhere to the pertinent aspects of Corporate and plant safety programs and adhering to GMP’s, ISO standards or other regulations.
Assist in investigating non-compliance investigations.
Assist with troubleshooting analytical methodology and instrumentation malfunctions.
Perform special assignments as directed by supervisor.
Assist in validation of manufacturing and production lines and equipment pertinent to chemistry (e.g. equipment and room cleaning validation) if requested.

REQUIREMENTS/PREFERENCES
In this position, the incumbent will be expected to draw upon previous analytical experience, as well as continuously learn Quality Control systems and effectively engage in relationships with peers in the laboratories, Manufacturing/Production, and personnel in other departments as needed. Once the incumbent is assigned specific materials on which to perform the quality control tests, or provide development or troubleshooting, the incumbent will have considerable impact on results from his/her work. Product can be rejected and manufacturing procedures can be altered significantly either in schedule changes or in process itself.

Education Requirement(s):
Bachelor’s degree in Chemistry, Biology, Pharmacy, or related 4 year science degree required. Chemistry degree is preferred.

Skill & Competency Requirements:
Knowledge, practical application, and understanding of analytical chemistry is required to perform the functions of this position.
Demonstrated capability for communicating ideas, concepts, and work results effectively to colleagues and supervision.
Demonstrated ability to be self-motivated as well as to work collaboratively in a team-based environment is required.
Must demonstrate initiative and a willingness to learn.
Good working knowledge of advanced laboratory instrumentation and personal computer skills are required.
Competencies required: analytical problem solving, alertness, work within established policies and procedures, commitment to task, decisiveness, effective written and interpretive communication skills, and organization and planning skills.
Experience in wet analytical methods and instrumentation techniques preferred; HPLC, UV, GC, IR, and AA preferred.

Preferences:
At least 1 year of lab experience preferred (outside of bachelor’s degree), preferably in pharmaceutical or nutritional industry.
A working knowledge of statistics, data processing and good manufacturing practices is desirable.
A thorough understanding of National Formulary (NF); United States Pharmacopoeia (USP); and European Pharmacopoeia (EP) testing procedures, as well as, US Pharmaceutical Industry Good Manufacturing Practices (GMP’s), quality control methods and procedures preferred.

Regulatory Submission Management and Planning, Whippany, NJ

DEPARTMENT
Regulatory Submission Management and Planning (RSMP)

DESCRIPTION
As a central eSubmissions expert, incumbent provides direct support to global submission teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions in scope.

Incumbent manages all aspects of document workflows associated with submission authoring, review, compilation, publishing and transfer on Health Registration Submissions worldwide using specialized software tools (e.g. docuBridge, documentum).

Has increasing submission management/coordination responsibilities for projects assigned in close interaction with the supervisor.

Additionally, the incumbent performs hands-on daily submission compilation and publishing activities associated with preparation of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and international submission types. This role includes partnering with RSMP colleagues at other sites to work on concurrent submission outlines and/or global dossier activities.

Interprets and applies all global regulatory guidance/regulations regarding format and structure to global submissions worldwide.

Responsible for implementing and promoting global electronic submission processes and document reengineering initiatives across Pharma. In addition, the incumbent will be responsible for capturing corporate knowledge regarding global submission standards and best practices across drug projects, contributing to global harmonization and transferring that knowledge to new submission teams. Knowledge transfer will include contributions to process documentation, format standards development, document template development, technical/process training.

Responsible for testing and release of new software functionality, and implementation of strategic technology initiatives related to dossier publishing.

POSITION DUTIES & RESPONSIBILITIES
Compiles and publishes documents/dossiers of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and international submission types.

For projects assigned, the incumbent executes all operational activities associated with compilation, publishing and distribution of submission dossiers for new and lifecycle management projects submitted to local and/or global Health Authorities. This includes partnering with GSM colleagues at other sites to work on concurrent submission outlines and/or global dossier activities.

Provides centralized expert support and guidance to global submission teams, internal RA stakeholders, cross-functional document authors, support staff, and publishers on the creation, preparation, tracking, publishing, QC/QA, and filing of Global submissions.
Has increasing submission management/coordination responsibilities for projects assigned in close interaction with the supervisor.

Works with submission team members to identify critical path of submission and then tracks all relevant dossier component deliverables as needed to assure timely submission of high quality dossiers.

Ensures achievement of submission milestone dates for assigned publishing support activities.
As part of the submission compilation process, coordinates the technical review / technical improvement and verification of the eCTD compliance of dossier-relevant R&D documents/reports consistent with appropriate standards.

Identifies and documents issues that risk the submission timelines and escalates the issues to management to recommend appropriate resolution.

Institutes and contributes to global harmonization of QA/QC policies and procedures for Global electronic submissions and associated workflow processes. Captures corporate knowledge regarding Global submission standards and best practices across drug projects and transfers that knowledge across project teams and disciplines (via process documentation, standards development, submission document template development, technical training and process training).

Develops, implements and maintains a comprehensive training curriculum associated with all aspects of the e-submission process. Acts as the Global Submissions functional area expert and lead trainer. Provides training of new and temporary Global Submissions staff as well as global project team members (cross-functional document authors).

Works with document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates. Works with internal stakeholders to maintain state-of-the-art e-submission authoring tools techniques (e.g. table captioning, document styles, cross-referencing, etc.). Monitors evolving agency regulations and assures submissions comply with all document/file formats and structures.

The position functions under the direct supervision of a Regulatory Submission Lead and/or Regulatory Submission Management. Incumbent must work well with other RSMP colleagues in a global network.

Interacts with RA-managers, GRT-members and cross-functional project team members responsible for authoring of submission documents and summaries and relevant business partners incl. R&D IT functions.

Interacts with Health Authorities and responds to inquiries specifically related to the technical merit of eCTD submissions.

REQUIREMENTS/PREFERENCES
Relevant experience may be met via a combination of electronic data/document management, project management, computer systems or publishing software support, electronic document publishing and/or regulatory affairs.

Knowledge of drug development process and relevant SOPs is required along with an understanding of federal regulations, international standards (e.g. ICH, IBH), and regulatory guidances as they pertain to the development and filing of e-submissons. The ability to interpret implications of these regulations, apply them to daily operations and to respond appropriately to questions from peers and cross functional professional staff is imperative.

Must have an excellent working knowledge of word processing, document management, and desktop publishing software packages, including hands-on knowledge of various document types, authoring tools and file formats (such as MS office templates, PDF file rendering, SAS program/transport files, XML program code, etc.). Additionally, previous experience with a document management or electronic publishing tools is needed (such as ISI Toolbox, docuBridge etc., though docuBridge / documentum experience preferred). Must have an excellent working knowledge of databases and data structures (such as Lotus Notes databases, Oracle IMPACT, MS Access, SAS, etc.).

Excellent verbal and written communication skills as well as interpersonal skills are needed to interact with various levels of international document authors and support staff across all disciplines. Multi-cultural sensitivity gained from some direct international experience is highly recommended. Ability to read and speak English fluently is mandatory.

Solid project management skills, tools and techniques and the ability to apply these directly to managing Regulatory submission projects is mandatory. Self-motivation, a sense of urgency, attention to detail, sound judgement, and good follow-through are also essential.

Education Requirement(s):

Minimum of a high school diploma 14+ yrs of progressively increasing responsibilities and relevant experience. Alternatively, a Bachelor degree and 6+ yrs of progressively increasing responsibilities and relevant experience or a Master degree and 5+ yrs of progressively increasing responsibilities and relevant experience.

Senior Lead Data Manager, Whippany, NJ

DEPARTMENT/TEAM DESCRIPTION
Oncology Business Unit – Medical & Data Management. Data management serves as key subject matter expert on topics related to data management activities. Contributions
include, but are not limited: vendor selection and management, mentoring junior staff, training team members, ongoing data review and reconciliation, project data management.

POSITION SUMMARY
The Senior Lead Data Manager (Sr. LDM) leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. The Sr. LDM may assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Oncology Data Management on the Core Study Team.

POSITION DUTIES & RESPONSIBILITIES
The Sr. Lead DM assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and applies Data Management best practices
Incorporates and maintains standards in clinical studies and projects for all elements of the
medical standards package.
Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in
QC activities, which includes, but is not limited to: initiating the SDMD, maintaining document
management systems, coordinating and ensuring contributions from relevant functions (i.e., EDC, CDC,
etc.), requesting a timely QC of the SDMD, informing relevant functions of results and ensuring proper
communication between functions, QC manager and self so that all issues are reconciled.
Specifies and develops study specific eCRFs, database structures and data consistency checks based
on medical standards, the Clinical Study Protocol and input from the study team.
Prepares, tracks and implements standard plans (i.e., GDM Study Plan, Data Management Plan,
Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up,
conduct and closure activities.
Accountable for data management activities necessary for the establishment of subject validity and
analysis set assignment, including but not limited to the following: specification of protocol deviations,
planning and conduct of interim and final Validity Review Meeting.
Supports study data management and data cleaning processes on an ongoing basis, applying study
specific documents and conventions.
Identifies and issues queries, incorporates query replies, tracks query status.

REQUIREMENTS/PREFERENCES
Education Requirement(s):
Bachelor’s degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation

At least 5 years of study and/or project level experience as a Data Manager in supportive and leading roles.

At least 2 years of experience should demonstrate responsibility as a study leader.
Good understanding of the drug development process
Strong organizational skills and able to collaborate with minimal supervision.

Preferences:
Basic SAS Programming knowledge, or other database experience
Significant experience in using data management methodologies and technologies (e.g. data warehousing, electronic data capture)
Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical Trials
Directive, Privacy rules [HIPPA], etc.)

Travel Requirements: none

Chemist, Shawnee, KS

DEPARTMENT/TEAM DESCRIPTION
This position provides essential support to the daily analytical operations of the pharmaceutical laboratory. All responsible areas are key activities in the analysis and results reporting for the ultimate release of finished goods for sale to market.

POSITION SUMMARY
The incumbent has primary working responsibilities in the following areas of day to day laboratory operations: Analyze Quality Control Samples including Raw Material, In-Process, Finished Product, Stability, Validation, and Special Samples. The incumbent ensures approved test methods are followed and proper record of analyses. Supporting the overall goals of the QA/QC organization, the incumbent provides assistance during investigations of any laboratory testing issues, utilizing problem solving skills and recommending potential solutions. The incumbent should be adept at developing standard operating procedures and test methods used in a laboratory environment.

On a daily basis, the incumbent must plan for and respond to the analytical needs of a laboratory involved in fast turnaround of pharmaceutical chemistry analyses to meet manufacturing deadlines. This planning requires good communication, attention to detail, organization skills and the use of the various analytical instrumentation systems and procedures.

POSITION DUTIES & RESPONSIBILITIES
The incumbent works as a team member in Pharm QC within raw materials or finished goods and is responsible for all analysis for product release.
Responsibilities include the preparation, analysis, and final result calculation for all analytical sample types submitted to Pharmaceutical QC as assigned.
Adherence to approved test methods and SOPs and proper documentation of laboratory raw data onto approved forms.
Plan for and respond to the analytical needs of the laboratory to ensure daily production schedules are met.
Ensure proper sorting and disposal of analytical sample solutions that are hazardous waste, and the chemical cleanliness of all work areas.
Assists weekly in laboratory supply and reagent inventory.
Assists in the development, creation or revision of standard operating procedures and test methods.
Provides support to laboratory projects and assist other team members as needed.

REQUIREMENTS/PREFERENCES
BA / BS in a related scientific field such as biology, chemistry, microbiology, or biochemistry.
1+ year laboratory experience, preferably in a chemistry laboratory.
Proven, effective written and verbal communication skills.
Demonstrated skills in the use of a wide range of analytical instruments and devices for the analysis of pharmaceutical substances and formulations are required. The incumbent should have the necessary experience and background to develop, create or revise standard operating procedures or test methods.
The incumbent should be proficient in the understanding, planning, and execution of laboratory Standard Operating Procedures relating to instrument use, sample analysis, document generation and control, personal safety, and environmental safety. Basic computer skills are required.
The incumbent must be able to pass a DEA background check.

Regulatory Affairs Associate, Whippany, NJ

JOB PURPOSE

The Regulatory Group in Nutritionals is responsible for the regulatory aspect of the labels. The goal of the department is to ensure label compliance and guarantee that our products meet the regulatory requirements with regard to proper labeling and nutritional information.

The Associate Regulatory Affairs position supports the team members in an effort to promote regulatory sound product labels and will be involved with a variety of tasks to ensure 100% compliance. The need for the position is driven out of the new federal labeling mandate as all labels will need to be revised and the workload associated with those changes has helped create the need for the position.

DUTIES AND RESPONSIBILITIES
Support regulatory activities associated with new and existing products in a variety of categories such as preparing labeling documentation, coordinating and reviewing labeling and advertising copy and labeling changes control.
Support efforts with regard to implementing the new federal labeling rule including creating presentations, maintaining spreadsheets and organizing materials for the Senior Associate Director.
Support team members by helping with new and existing products responsibilities.
Review and approve promotional material.
Prepare and approve labeling graphics.
Prepare, review and manage change control for product labeling.
Review new legislation and prepare detailed summaries on its impact

REQUIREMENTS AND PREFERENCES
Education requirement:
Bachelor’s degree

Skills and competencies experience
2 years of relevant experience in regulatory setting with dietary, supplement, food, or OTC products
Experience multi-tasking in a deadline controlled and highly regulated environment
Ability to communicate effectively in English both verbally and in writing
Proficiency in MS Office
Team and customer orientation
Results driven

Preferences:
Bachelor degree in life sciences, preferably nutrition or biology

Associate Regulatory Submission Manager, Whippany, NJ

DESCRIPTION
As a central eSubmissions expert, incumbent provides direct support to global submission teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions in scope.

Incumbent manages all aspects of document workflows associated with submission authoring, review, compilation, publishing and transfer on Health Registration Submissions worldwide using specialized software tools (e.g. docuBridge, documentum).

Has increasing submission management/coordination responsibilities for projects assigned in close interaction with the supervisor.

Additionally, the incumbent performs hands-on daily submission compilation and publishing activities associated with preparation of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and international submission types. This role includes partnering with RSMP colleagues at other sites to work on concurrent submission outlines and/or global dossier activities.

Interprets and applies all global regulatory guidance/regulations regarding format and structure to global submissions worldwide.

Responsible for implementing and promoting global electronic submission processes and document reengineering initiatives. In addition, the incumbent will be responsible for capturing corporate knowledge regarding global submission standards and best practices across drug projects, contributing to global harmonization and transferring that knowledge to new submission teams. Knowledge transfer will include contributions to process documentation, format standards development, document template development, technical/process training.

Responsible for testing and release of new software functionality, and implementation of strategic technology initiatives related to dossier publishing.

POSITION DUTIES & RESPONSIBILITIES
Compiles and publishes documents/dossiers of various dossier types, for both new product marketing applications and/or marketed product maintenance packages. This includes both domestic and international submission types.

For projects assigned, the incumbent executes all operational activities associated with compilation, publishing and distribution of submission dossiers for new and lifecycle management projects submitted to local and/or global Health Authorities. This includes partnering with GSM colleagues at other sites to work on concurrent submission outlines and/or global dossier activities.

Provides centralized expert support and guidance to global submission teams, internal RA stakeholders, cross-functional document authors, support staff, and publishers on the creation, preparation, tracking, publishing, QC/QA, and filing of Global submissions.
Has increasing submission management/coordination responsibilities for projects assigned in close interaction with the supervisor.

Works with submission team members to identify critical path of submission and then tracks all relevant dossier component deliverables as needed to assure timely submission of high quality dossiers.

Ensures achievement of submission milestone dates for assigned publishing support activities.
As part of the submission compilation process, coordinates the technical review / technical improvement and verification of the eCTD compliance of dossier-relevant R&D documents/reports consistent with appropriate standards.

Identifies and documents issues that risk the submission timelines and escalates the issues to management to recommend appropriate resolution.

Institutes and contributes to global harmonization of QA/QC policies and procedures for Global electronic submissions and associated workflow processes. Captures corporate knowledge regarding Global submission standards and best practices across drug projects and transfers that knowledge across project teams and disciplines (via process documentation, standards development, submission document template development, technical training and process training).

Develops, implements and maintains a comprehensive training curriculum associated with all aspects of the e-submission process. Acts as the Global Submissions functional area expert and lead trainer. Provides training of new and temporary Global Submissions staff as well as global project team members (cross-functional document authors).

Works with document authors across all disciplines to develop and maintain a comprehensive set of e-submission document templates. Works with internal stakeholders to maintain state-of-the-art e-submission authoring tools techniques (e.g. table captioning, document styles, cross-referencing, etc.). Monitors evolving agency regulations and assures submissions comply with all document/file formats and structures.

The position functions under the direct supervision of a Regulatory Submission Lead and/or Regulatory Submission Management. Incumbent must work well with other RSMP colleagues in a global network.

Interacts with RA-managers, GRT-members and cross-functional project team members responsible for authoring of submission documents and summaries and relevant business partners incl. R&D IT functions.

Interacts with Health Authorities and responds to inquiries specifically related to the technical merit of eCTD submissions.

REQUIREMENTS/PREFERENCES
Relevant experience may be met via a combination of electronic data/document management, project management, computer systems or publishing software support, electronic document publishing and/or regulatory affairs.

Knowledge of drug development process and relevant SOPs is required along with an understanding of federal regulations, international standards (e.g. ICH, IBH), and regulatory guidances as they pertain to the development and filing of e-submissons. The ability to interpret implications of these regulations, apply them to daily operations and to respond appropriately to questions from peers and cross functional professional staff is imperative.

Must have an excellent working knowledge of word processing, document management, and desktop publishing software packages, including hands-on knowledge of various document types, authoring tools and file formats (such as MS office templates, PDF file rendering, SAS program/transport files, XML program code, etc.). Additionally, previous experience with a document management or electronic publishing tools is needed (such as ISI Toolbox, docuBridge etc., though docuBridge / documentum experience preferred). Must have an excellent working knowledge of databases and data structures (such as Lotus Notes databases, Oracle IMPACT, MS Access, SAS, etc.).

Excellent verbal and written communication skills as well as interpersonal skills are needed to interact with various levels of international document authors and support staff across all disciplines. Multi-cultural sensitivity gained from some direct international experience is highly recommended. Ability to read and speak English fluently is mandatory.

Solid project management skills, tools and techniques and the ability to apply these directly to managing Regulatory submission projects is mandatory. Self-motivation, a sense of urgency, attention to detail, sound judgement, and good follow-through are also essential.

Education Requirement(s):

Minimum of a high school diploma 14+ yrs of progressively increasing responsibilities and relevant experience. Alternatively, a Bachelor degree and 6+ yrs of progressively increasing responsibilities and relevant experience or a Master degree and 5+ yrs of progressively increasing responsibilities and relevant experience.

Microbiology Lab Tech, Cleveland, TN

POSITION/TITLE: Microbiology Laboratory Technician

POSITION DUTIES & RESPONSIBILITIES
Entry level job that supports the laboratory operations in a FDA regulated GLP environment and primary job functions of the Laboratory Technician include:

• Tracking and documentation of all laboratory consumables (media, reagents, buffers, culture records etc.)
• Preparation media and buffers, operation of laboratory equipment including
• steam sterilizers(autoclaves).
• Follows standard operating procedures and maintains ongoing training requirements.
• Perform calibration of laboratory equipment and daily equipment verifications as well.
• Adherence to good documentation practices when reporting results.
• Characterization of microorganisms and cultivation of reference stock cultures
• Participates in and supports ongoing projects (5S, continuous improvement projects etc.)

Employee must work well with all laboratory personnel in a team environment, as well as colleagues in other sections of Quality Operations and the site. Employee must have a Safety mindset. This position has a high potential to work seasonal overtime.

REQUIREMENTS/PREFERENCES

Education Requirement(s):
• Bachelor’s Degree in Biology, Microbiology or related fields
• At least one year work experience in a FDA regulated GLP environment is preferable

Skill & Competency Requirements:
• Effective computer skills
• Effective communication skills
• Effective writing skills

Systems Analyst (HR), Pittsburgh, PA

DEPARTMENT/TEAM DESCRIPTION
HRIS (Human Resources Information Systems) Department – Responsible for managing and maintaining employee data, managing and maintaining organizational management structure in SAPHR, providing SAPHR system support, 3rd Party interface support, Ad Hoc Reporting, HR Data Analytics

POSITION SUMMARY
Coordinate all activities concerning HR system and interface
landscape within global HR community, hosting partners and software
providers. Solves complex individual inquiries, which require specific HR knowledge
and policy interpretation as well as knowledge of legal
requirements for individual processes. Administers exceptions to
processes and coaches HR Services Associates & Professionals in process
area of specialization.

POSITION DUTIES & RESPONSIBILITIES

• Manages and promotes efficient HR Services delivery of their
specific process as well as corresponding interfaces, proactively
identifies service delivery issues by taking appropriate actions to
resolve and generally improve quality standards and metrics (including
third party KPIs). Responsible for all exceptions in administration of
specific process.
• Proactively involved in cross departmental groups and projects to
drive an integrated HR service.
• Demonstrates clear overview about HR processes, changes, project
requests and developments within a country and supports in coordination
as needed.
• Maintains responsibility for or handles highly complex queries
and intense consulting needs of defined HR processes as well as ensuring
administrative and coordinative support for other HR related queries.
Takes ownership for resolution of those queries ensuring timely,
accurate and value add responses.
• Ensures local support and knowledge for incident/problem
management for local topics based on global steering and rules.
• Ensures contact with HR Experts and other HR Senior Professionals
and proactively drives development, maintenance and improvement of
detailed knowledge management of designated processes and interfaces for
countries covered.

REQUIREMENTS/PREFERENCES
Education Requirement(s):
• Bachelor’s degree (technical or business degree)

Skill & Competency Requirements:

– 5+ years of experience in the range of HR system development, implementation and maintenance
– Knowledge of system techniques (esp. for HR) and HR development
– Good knowledge of specific features in the area of HR System Landscape Management (e.g. SAP system configuration)
– 3+ years of experience of necessary tools (MS Access, SQL, and Excel)

– Demonstrated collaborative skills and ability to work well within a team
– Strong analytic problem-solving, critical-thinking skills
– Sound organizational skills to work in a fast-paced environment and manage multiple priorities

Preferences:
• SAP HR experience
• Project management experience
• Experience creating medium to complex reports (SQL, Access)

RandD Software Developer, Morristown, NJ

R&D IT Sr Software Developer

DEPARTMENT/TEAM
DESCRIPTION

R&D IT – Research & Development IT department supporting Clinical, Medical Affair and Pharmacovigilance areas

POSITION SUMMARY

The position will be responsible for the application development and maintenance in order to support R&D MAPV as well as Clinical areas. The task is to create and enhance software in the MAPV and Clinical areas. The role has to closely align all activities with the application managers and project managers in this areas.

POSITION DUTIES & RESPONSIBILITIES
• Individually responsible for software development and support of IT applications & prototypes, used by Pharmacovigilance, Medical Affairs and Clinical.
• Apply knowledge and expertise to validate data integrity and compliance to ensure IT applications are aligned with requirements.
• Has to deliver on business operational needs and the results will meet compliance guidelines.
• Apply domain knowledge to received change requests; identify software bug issues and general concerns in order to effectively prioritize work. Incumbent will need to effectively manage priorities, communicate with stakeholders; research scope of work change requests will require, manage change request approval process and triage issues in an effective manner to ensure business disruptions are minimized.
• Leads development by coordinating with IT consultants and application managers for MAPV applications and proof of concepts to deliver innovative solutions in an agile environment ensuring aligned with IT strategy.
• Drives innovation for IT solutions in an area where general movement is to paperless/no touch environment with continuous integration and continuous deployment.
• Responsible for leading and delivering on software testing life cycle for changes to existing and development of new applications. Inclusive of validating requirements, gaining approval for testing plan, creating test cases, executing test cases, triaging defects, and obtaining sign off for test results with the business.
• Makes independent decisions within scope of responsibility.
• Takes ownership in keeping up-to-date on current.

REQUIREMENTS/PREFERENCES
Education Requirement(s):
• Bachelor’s Degree with 8+ years of experience
• OR Master’s Degree with 6 Years OR Doctorate with 1+ Years OR 12+ Years applicable business experience.

Skill & Competency Requirements:
• Knowledge about Medical Affairs and Pharmacovigilance business- and development processes
• Expert in at least one technology area like cloud, etc. and have the proven ability to execute quickly on ideas by building prototypes.
• Experience with different software design patterns and produce simple and understandable code.
• Experience with HTTP, RESTful APIs or JAVA, JSP, JavaScript and Servlets.
• Experience with open source frameworks like SPRING, STRUTs, MAVEN and etc.
• Proficient with Linux, databases (preferably Oracle “PLSQL”), scripting and version control (preferably subversion).
• Experience with continuous integration and continuous deployment and know the tools of the trade.
• Successfully applied the concept of test-driven development and are used to setup automated testing.

Preferences
• Proficiency with R, SAS, or Python and can perform statistical analyses of various complexities.
• Experience in developing nside a cloud environment (e.g. AWS).

Enter here Travel Requirements: NONE

Medical Writing Coordinator, Whippany, NJ

POSITION/TITLE:
Medical Writing Coordinator

DEPARTMENT/TEAM
CS Medical Writing

DESCRIPTION
Most medical writing projects managed by the Global CS Medical Writing group involve the development of complex documents that are made up of multiple sections being sourced from multiple authors in multiple formats. The multiple sections are then compiled and published into the final document.
The CS Medical Writing Coordinator reports to the Head of CS Medical Writing and is responsible for the tracking, quality control timely completion of the clinical documents related to global regulatory submissions across all therapeutic areas for these complex medical writing projects and for training new Medical Writing Coordinators. These projects include Clinical Study Reports (CSRs), abbreviated CSRs, and Regulatory Submission Documents (e.g. Module 2.7.1 and 2.7.2).
In addition, the incumbent is responsible for maintaining all databases used by the Medical Writer to track and manage the overall medical writing process.

POSITION SUMMARY
Provide a general overview of why the job exists; and what the job is to accomplish.

POSITION DUTIES & RESPONSIBILITIES
• Uses project management skills to coordinate, track, review and ensure timely completion of high quality documents.
• Provides to the medical writer (located either locally or remotely) assigned to a writing project, all source documentation from the electronic archive needed to author the document (e.g. statistical table sets, reference documents, subject data listings, etc.).
• Manages CSR process starting from database closure up to final CSR registration for studies with an external medical writer.
• Independently compiles complete drafts of report appendices for clinical phase 1 /2a studies.
• Act as a central resource on all format- and style-related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintain departmental and project-specific style guides to reflect new agreements and changes due to SOPs, WPs, and regulatory guidelines. Provide updates to all medical writers (internal and external) regarding style, format, and content decisions.
• Work with key interface partners to facilitate the completion of clinical study reports and their appendices. Ensure clinical documents adhere to global standards and are in accordance with electronic publishing Standards. Checks that study file components (e.g. Investigator CV’s, protocol and amendments, sample case report form) needed for the writing of CSRs are checked into the electronic archive (e.g. eDMS) on a timely basis (i.e. based on agreed upon timelines for a writing project) and meet all global standards and regulatory requirements for format (e.g. heading styles, language, accuracy).
• Proofreads, reformats and edits document text, as required, to ensure that all report appendices meet all requirements for formatting (e.g. styles, fonts, etc.) prior to final QC, compilation and publishing. Reviews and performs QC checks of all documents and appendices to ensure consistency between and within documents.
• Manages the review and approval of documents in the document management system using standard procedures. Transfers clinical study documents from the individual study files into the electronic archive used to compile the final medical documents.
• Ensures that all team members have the required document management and review tool training required to review, approve and sign documents and trains them if necessary
• Supports the training of new medical writing specialists and coordinators

REQUIREMENTS/PREFERENCES
Bachelor’s degree or equivalent with at least 3-5 years of experience the pharmaceutical industry in total, including a minimum of 2 years in Medical Writing and demonstrated working knowledge of scientific principles. OR
have an Associate’s Degree with at least 5-7 years of experience in these areas.
AND
The incumbent should have familiarity with clinical research, statistics, and regulatory guidances, standards and requirements pertaining to regulatory medical writing world wide (e.g. ICH, FDA, EMEA).
Experience should include working with complex documents, preferably pharmaceutical research and submission documents (e.g. clinical study protocols, clinical study reports, other submission documents.
The incumbent must have experience in electronic document management and electronic regulatory submissions, tools and standards (e.g. Documentum based systems, Adobe Acrobat, ISI-Toolbox).
The incumbent must be able to work on a wide variety of medical writing projects and support multiple scientific writers with minimal supervision. He/she must be highly organized and capable of setting up and maintaining the necessary procedures to ensure all projects are completed according to agreed timelines.
The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.
The incumbent must be a skilled user of word processing applications (e.g. Microsoft Word and Excel).

Assistant Research Scientist - Morrisville, NC

Description:

 

POSITION/TITLE: Assistant Research Scientist

Preference is to have 1-2 years experience in the field.

DEPARTMENT/TEAM
Trait Research / Trait Validation / Vectoring group

DESCRIPTION
The Vectoring group is part of the Trait Research group CropScience. The vectoring group’s main purpose is to make DNA plasmids used for plant transformation.

POSITION SUMMARY
The primary responsibility of this role is to construct plant transformation vectors, optimize gene expression, and helps in other areas if needed. This position is expected to produce on-time critical research milestones to support ongoing research.

POSITION DUTIES & RESPONSIBILITIES
Design and construct plant transformation vectors with minimal supervision:
Use general molecular biology techniques to obtain requested constructs, those techniques include PCR, agarose gel electrophoresis, miniprep, cloning techniques…
Generate NGS libraries and analyze sequence and expression data:
Use kits to generate high quality NGS libraries, use softwares for analysis of sequencing results, put together reports to present the results.
Prepare adequate reports and inform group members:
Effectively use electronic notebook to record experiments performed, draw conclusions and share findings with group members.
Manage confidentiality of competitive know-how.
Ensure compliance with all existing safety and stewardship standards in the area of responsibility, taking into account laws, regulations and directives.

REQUIREMENTS/PREFERENCES
Education Requirement(s):
BS in a Molecular Biology or related field (Molecular Biology, Microbiology, Biotechnology…)

Skill & Competency Requirements:
1 Good understanding of Molecular Biology (DNA structure…) and Molecular Biology techniques (PCR, miniprep, restriction digest and ligation…)
2 Proven ability to learn and follow previously defined protocols well.
3 Self-drive – work independently and reach goals without monitoring needed.
4 Ability to work both independently and within a team.

Other nice to have skills:
– Experience with Next Generation libraries preparation and sequence analysis
– Knowledge of cloning software.

No travel.

 

Interested candidates should send their resumes to, [email protected]

Chemical Technician - Kansas City, MO

Description:

 

POSITION/TITLE: Lab Analyst I

RATES
Pay rate: $16.70/hr training pay; Post training $18.70/hr; Night shift extra pay $2/hr

DEPARTMENT/TEAM DESCRIPTION
This position is in a Quality Control laboratory in a agricultural chemicals manufacturing
plant. The laboratory performs routine testing on intermediates, final products, and waste
byproducts produced at the site.

POSITION SUMMARY
This position performs routine testing on all samples in the Analytical Services laboratory,
providing analytical data for process control, quality control, process development, product
development, and waste management.

The laboratory operates 24 x 7. The shift and days off for the applicant have not been
determined. All applicants for this position should be open to working any of the three lab
shifts and any days of the week including overnights and weekends. Lab shifts are
overnights 8pm-6:30am, days 6am-2:30pm and evenings 10am-8:30pm.

POSITION DUTIES & RESPONSIBILITIES
• Performs routine analytical testing on teams that work a variety of shifts that include
working weekends and holidays. Requests additional work to increase team productivity.
•Prepares and analyzes numerous types of samples by a variety of physical and chemical
analytical techniques using sophisticated analytical equipment. The instrumentation
includes pH meters, densitometers, dissolved oxygen meters, conductivity meters,
calorimeters, viscometers, rheometers, spectrophotometers, auto-titrators, ion
chromatographs (IC), inductively coupled plasma spectrometers (ICP), laser particle size
analyzers, gas chromatographs (GC), High Pressure Liquid Chromatographs (HPLC),
titrators, densitometers, auto-claves, pipettors, platers, incubators, and ovens.
• Performs various microbiological tests including tests to determine spore counts and
microbiological contamination.
• Understands and operates STARLiMS Laboratory Information Management System
(LIMS), Waters Empower laboratory data acquisition system, and other instrument-specific
computer systems.
• Searches various databases for test methods, specifications, and standards to locate
information required to complete analyses. Promptly and accurately records, calculates and
reports analytical results.
• Maintains appropriate records to meet internal requirements as well as, ISO 9001, 14001,
and 18001. Completes various daily instrument calibrations and inspections.
• Observes good safety and housekeeping practices. May serve as Safety Officer for the
shift.
• Maintains laboratory supplies, prepares solutions, cleans glassware, disposes of
solid/liquid waste and other duties to help in the overall operations of the laboratory. Trains
others on waste management.
• Follow oral and written instructions.
• Reviews analytical data and various LIMS reports. Communicates and discusses any
issues with other team members and supervision.
• Participates on continuous improvement sub-teams.
• Knowledgeable of RCRA hazardous waste regulations, waste determinations, waste
codes, and how to immediately communicate discovery of spills and leaks. Also must know
labeling, inspection, and recordkeeping requirements to accumulate waste in: satellite
accumulation areas, less than 90-day containers, and less than 90-day tanks.
• Initial RCRA hazardous waste training shall be completed within 6 months of starting job,
and refresher training shall occur annually thereafter, per 40 §265.16.

REQUIREMENTS/PREFERENCES
Education Requirement(s):
• High school diploma and 2 years of analytical chemical laboratory experience. This
experience should include doing chemical analyses.
• 10 -20 hours college chemistry and some experience in a chemical laboratory
• BS degree in a science discipline and 0 years laboratory experience.

Skill & Competency Requirements:
• Good oral and written communication skills.
• High attention to details and an ability to analyze outcomes against a standard.
• Ability to diagnose the typical instrument problems with little or no assistance and provide
assistance to others.
• Ability to multi-task and prioritize workload to optimize efficiency and productivity of the
laboratory
Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills,
abilities, etc.)
• Understands basic HPLC and GC operation

Interested candidates should sent their resumes to, [email protected]

Chemist - Shawnee, KS

POSITION/TITLE: Chemist I

DEPARTMENT/TEAM DESCRIPTION
This position provides essential support to the daily analytical operations of the pharmaceutical laboratory. All responsible areas are key activities in the analysis and results reporting for the ultimate release of finished goods for sale to market.

POSITION SUMMARY
The incumbent has primary working responsibilities in the following areas of day to day laboratory operations: Analyze Quality Control Samples including Raw Material, In-Process, Finished Product, Stability, Validation, and Special Samples. The incumbent ensures approved test methods are followed and proper record of analyses. Supporting the overall goals of the QA/QC organization, the incumbent provides assistance during investigations of any laboratory testing issues, utilizing problem solving skills and recommending potential solutions. The incumbent should be adept at developing standard operating procedures and test methods used in a laboratory environment.

On a daily basis, the incumbent must plan for and respond to the analytical needs of a laboratory involved in fast turnaround of pharmaceutical chemistry analyses to meet manufacturing deadlines. This planning requires good communication, attention to detail, organization skills and the use of the various analytical instrumentation systems and procedures.

POSITION DUTIES & RESPONSIBILITIES
• The incumbent works as a team member in Pharm QC within raw materials or finished goods and is responsible for all analysis for product release.
• Responsibilities include the preparation, analysis, and final result calculation for all analytical sample types submitted to Pharmaceutical QC as assigned.
• Adherence to approved test methods and SOPs and proper documentation of laboratory raw data onto approved forms.
• Plan for and respond to the analytical needs of the laboratory to ensure daily production schedules are met.
• Ensure proper sorting and disposal of analytical sample solutions that are hazardous waste, and the chemical cleanliness of all work areas.
• Assists weekly in laboratory supply and reagent inventory.
• Assists in the development, creation or revision of standard operating procedures and test methods.
• Provides support to laboratory projects and assist other team members as needed.

REQUIREMENTS/PREFERENCES
• BA / BS in a related scientific field such as biology, chemistry, microbiology, or biochemistry.
• 1+ year laboratory experience, preferably in a chemistry laboratory.
• Proven, effective written and verbal communication skills.
• Demonstrated skills in the use of a wide range of analytical instruments and devices for the analysis of pharmaceutical substances and formulations are required. The incumbent should have the necessary experience and background to develop, create or revise standard operating procedures or test methods.
• The incumbent should be proficient in the understanding, planning, and execution of laboratory Standard Operating Procedures relating to instrument use, sample analysis, document generation and control, personal safety, and environmental safety. Basic computer skills are required.
• The incumbent must be able to pass a DEA background check.

Interested candidate should send their resumes to, [email protected]

Temp. Agricultural Lab Assistant - Maricopa, AZ

Summary:
Assist Breeding, Molecular Breeding and Nursery Services Cotton Program.

Job Duties include but not limited to:
1.Transgenic leaf sampling and crossing activities as needed.
2.Bagging plants in field.
3.Lab work: Transferring leaf sampling to plates.

Education requirements- High School Diploma/GED

Note: Temporary Labor may be trained on other duties not listed.

Temp. Agricultural Lab Technician - Brooks, OR

POSITION/TITLE: QC Laboratory Technician

DEPARTMENT/TEAM DESCRIPTION QC Seed Health, primary function is to test vegetable seeds (carrot, onion, cucurbit, tomato) for the presence of specific bacterial/viral/fungal pathogens.

POSITION SUMMARY Technician will provide support of QC Seed Health lab according to accredited protocols, procedures and guidelines

POSITION DUTIES & RESPONSIBILITIES
� Preparation of seed samples for test methods to support lab activities.
� Ensure that all required tests are performed in a timely and accurate manner following established global guidelines. Understand basic microbiological principles and ensure test results processing procedures are followed. Ensure performance of Quality Control tests according to accreditation standards, procedures, work instructions and annexes.
� Operate and maintain equipment involved in various testing and preparation procedures including autoclaves, mediaclaves, grinding equipment, scales, laboratory hoods and other machinery.
� Understand the importance and nature of chemicals, and ensure the standards/specifications are met while using them.
� Handle quarantine pathogens according to company hygiene policy and procedures.
� Prepare and plant QC tests on vegetable seeds.
� Participate in auditing sessions as needed, ensuring adherence to all global standard operating procedures. Actively cooperate to implement and follow corrective and preventive actions based on the outcome of both internal and external audits.
� Perform other duties or responsibilities as required or assigned.

REQUIREMENTS/PREFERENCES
� Minimum education required: High school diploma.
� Preferred: Associates or Bachelor’s in Science (Biology/Agriculture in particular) Skill &

Competency Requirements:
� Team player
� Interest in Agriculture/Laboratory work
� Willingness to learn new techniques
� Flexibility, openness to change amidst ambiguity
� Ability to lift up to 30 pounds
� Willingness to perform monotonous/repetitive work. Travel Requirements: N/A

Cloud Engineer - Tarrytown, NY

In this role, you will be responsible for providing the specification and architecture for new products, requirements analysis, as well as design and development of cloud infrastructure for data capture and data integration with medical devices and healthcare applications. To be considered for this role, you will need a Bachelor of Science in Computer Engineering, Computer Science or Electrical Engineering, with six plus years of experience, or a Masters with four plus years of experience. Experience with client-server transaction-level synchronization and back-end synchronization/replication along with a proven record in full life-cycle software development and delivery experience.

Sr. Software Cloud Engineer job duties:
•Development and design of client-server software modules and protocols/APIs to integrate devices and application systems, including Bluetooth enabled devices, mobile device applications and cloud enabled applications.
•Design and implementation of MSMQ (Microsoft Messaging Queue) and AppFabric Cache.
•Deliver solutions in support of full life-cycle implementation of software products and systems utilizing a structured, documented software development process and generally accepted software engineering methods.
•Document requirements specification and protocol API creation and subsequent maintenance of technical documentation in support of quality system and process requirements.
•Active participation in offerings development by reviewing specification and risk assessment. Provide detailed input to R&D team members regarding the technical feasibility of proposed designs, technical risks, and potential mitigation strategies.

Qualifications:
•Bachelor of Science in Computer Engineering, Computer Science or Electrical Engineering, with six plus years of experience, or MS with four plus years of experience.
•Experience with client-server transaction-level synchronization and back-end synchronization/replication.
•Proven record in full life cycle software development and delivery.
•Design and implementation knowledge for Authorization/Authentication services including standards such as oAuth.
•Experience programming (.NET)
Programming OO
Programming Design Patterns
Programming Web Services
• Relevant Microsoft technologies
IIS
SQL Server, SSIS, SSRS
Entity Framework,
WCF Framework, WPF (Windows Presentation Foundation)
•Minimum two years Azure working experience.
•Experience with SQL and NoSQL DBs.
•Understanding of hybrid cloud solutions and experience of integrating public cloud into tradition/private hosting/cloud models.

RandD Software Engineer - Tarrytown, NY

In this role, you will be responsible for taking assignments for service, installation, and customer training and driving them to completion. To be considered for this role, you will have a Bachelor’s of Science degree in Computer Engineering, Computer Science or Electrical Engineering with six plus years of experience, or MS with four plus years of experience. Must have strong experience programming in .NET and must have knowledge of analytics platforms, such as PowerBI or Tableau.

R&D Software Developer job duties:

•Development and design of client-server software modules and protocols/APIs to integrate devices and application systems, including Bluetooth enabled devices, mobile device applications and cloud enabled applications.
•Design and implementation of MSMQ (Microsoft Messaging Queue) and AppFabric Cache.
•Support the development of reporting and Analytics solutions using platforms such as SSRS, Power BI and Tableau.
•Deliver solutions in support of full life-cycle implementation of software products and systems utilizing a structured, documented software development process and generally accepted software engineering methods.
•Conceptual design and subsequent development of feasibility prototypes of system features and technology.

Qualifications:

•Bachelor of Science in Computer Engineering, Computer Science or Electrical Engineering, with six plus years of experience, or MS with four plus years of experience.
•Experience with client-server transaction-level synchronization and back-end synchronization/replication.
•Experience with data integrations using API, Authorization/Authentication services using standards like oAuth and tools like OWIN.
•Strong experience with programming in .NET.
•Experience with one or more BI and Analytics platforms such as Tableau, PowerBI, QlikView, Spotfire, etc

Senior BI Engineer - Bridgeville, PA

You’ll use the latest versions of relational and non-relational platforms to build, maintain and support  analytics systems. You will extend traditional data warehouse architectures through cloud data services. And you’ll use cutting edge data visualization tools to provide compelling reporting every step of the way.

Responsibilities

  • Strong expertise and experience on design and development of platforms, metric systems, or online experimentation systems with a track record of shipping multiple releases.
  • Extensive software design and development skills/experience (minimum 5 years, preferred: 7 years)
  • Substantial hands-on experience with Analysis Services development, testing and deployment, with a particular focus on SQL Server Analysis Services (Tabular) and DAX
  • Expert knowledge in .NET, C#, SQL, and Windows
  • Deep understanding of efficient data structures and algorithms.
  • Working knowledge and/or experience with Power BI (Power BI Online, Power BI Desktop) and related tools
  • Working knowledge and/or understanding of Azure-based tools and services that support data storage, e.g. Azure SQL, Blob and Table Storage,
  • Strong understanding and hand-on experience in Spark,  uSQL, ADL, Azure,  Microsoft Azure HDInsight,  SaaS, etc. to deeply understand cloud computing techniques.
  • Excellent analytical skills Ability to drive sound architecture, design, and implementation through hands-on development.
  • Work requires analytical ability to integrate and interpret data from diverse sources to identify solutions. Must be able to analyze reports, notice discrepancies, prepare analysis, and provide statistical productivity data to various departments.
  • Experience in Designing and plan BI solutions , Debugging, monitoring and troubleshooting BI solutions, Creating and deploying reports and Writing relational and multidimensional database queries .
  • Architectural design and development of a very large scale and high-quality data platform with easy to use APIs, or streaming data processing, or interactive data querying, or metadata driven metrics& reporting systems.
  • Any experience in NOSQL environment is a plus.
  • Make the platforms and systems highly efficient in term of both its execution and the consumption of the data it generates.

Competencies

  • Interpersonal skills and team player to maintain collaborative relationships throughout the company and with customers.
  • Experience in a customer-facing, support, consulting or sales role.
  • Attention to detail, especially with written work such as legal contracts and customer-facing communications.
  • Ability to think and work analytically.
  • Ability to work independently.
  • Ability to document policies, procedures and technical diagrams.
  • Ability to manage a substantial unplanned workload with short deadlines.
  • Superior communication skills, both verbal and written.
  • Bachelor’s degree in computer science or related areas is required
  • Passionate and self-motivated learner and be able to adapt to newer technologies and working in agile process oriented teams.

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