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QC Documentation Specialist in Andover, MA at Apex Life Sciences

Date Posted: 12/7/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a QC Documentation Specialist in the Andover, MA area!

DUTIES

  • Provide non-testing support for raw material testing for new and existing product in a cGMP Quality Control Analytical (QCA) department.
  • This support includes writing and revising technical documents (procedures, test methods, raw material specifications) for new and existing raw materials associated with cGMP testing, compendial updates, investigations, change controls, method verification/validation, LabWare Laboratory Information Management System (LIMS) support, visual management and continuous improvement.
  • Responsible documentation support as an individual and through collaboration with laboratory subject matter experts (SMEs).
  • Organize and prioritize workload with manager to meet all timelines and deliverables in the support of the plan of record and to ensure compliance.
  • Revise and author GMP documents
  • Author GMP laboratory investigations
  • Author change control documents
  • Evaluate compendial changes and impact on GMP procedures and specifications
  • Evaluate impact of changes on laboratory information management system (LIMS)
  • Create change requests for LIMS
  • Support continuous improvement projects and actions
  • Manage projects and coordinate timelines with stakeholders

SKILLS

  • A BS degree in science, engineering, computer science, or related technical discipline.
  • 3-5 years pharmaceutical/biopharmaceutical experience in a relevant GMP role such as QC or QA
  • Strong background in Chemistry desired
  • Raw Materials experience strongly preferred
  • Past experience working with QC documentation in the biopharmaceutical field is preferred

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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