Quality Assurance Specialist

2 weeks ago


St Louis, Missouri, United States Thermo Fisher Scientific Full time
About the Role

We are seeking a highly skilled QA Engineer II to join our team at Thermo Fisher Scientific. As a QA Engineer II, you will play a critical role in ensuring the quality and compliance of our pharmaceutical production processes.

Key Responsibilities
  • Coordinate and oversee the day-to-day quality oversight of contract manufactured biologic molecules.
  • Provide quality-minded problem resolution to on Manufacturing and Quality Control activities and any critical issues stemming from production and Quality On the Floor.
  • Supervise and coordinate resolutions of issues and communicate as needed to other QA Engineers or Manager.
  • Perform review and approval of GMP documents such as Batch Records, Standard Operation Procedures/Controlled Documents, Technical Transfer Protocols, Deviations, CAPAs, Change Controls, and other Quality Records.
  • Assist Product Quality Leads during technology transfer of new products; ensuring development of process adheres to governing regulations based on phase appropriate FDA, EMA and ICH guidelines.
  • Perform routine quality walk throughs of assigned production and production support areas.
  • Participate in site inspection readiness activities, inspections, client face to face meetings and core team meetings.
Requirements
  • Bachelor's Degree in biology, biochemistry, chemistry or other science related field preferred or equivalent experience in lieu of education requirements.
  • 3+ years of experience in a GMP Environment. 1-3 years of experience within a professional level Quality Assurance, Quality Operations, or Compliance preferred.
  • Knowledge of industry standards and cGMP regulations.
  • Ability to apply GMP/GLP regulations and other international guidelines to all aspects of the position.
  • Able to aseptically gown and work in environmental clean rooms, as needed.
  • Proficient knowledge of controlled documentation and data systems.
About Us

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.



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