Engineer II, QA

Thermo Fisher Scientific - St. Louis, MO

Full-time - Mid Level

St. Louis, MO

Computer and Electronic Product Manufacturing

About the position

The QA Engineer II position at Thermo Fisher Scientific is a Quality Assurance role focused on ensuring quality oversight of pharmaceutical production and problem resolution on the Quality Control and Manufacturing floor. This role involves coordinating day-to-day oversight of contract manufactured biologic molecules, reviewing and approving GMP documents, and participating in site inspections and client meetings. The position is critical in maintaining compliance with industry standards and regulations while supporting the development of new products.

Responsibilities

• Coordinate and ensure successful day-to-day oversight of contract manufactured biologic molecules.
• Provide quality-minded problem resolution to Manufacturing and Quality Control activities.
• Supervise and coordinate resolutions of issues and communicate with other QA Engineers or Manager.
• Perform review and approval of GMP documents such as Batch Records, SOPs, Technical Transfer Protocols, Deviations, CAPAs, and Change Controls.
• Assist Product Quality Leads during technology transfer of new products, ensuring adherence to 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 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 in Quality Assurance, Quality Operations, or Compliance preferred.
• Experience with SAP, TrackWise, and/or Documentum is suggested.
• Knowledge of industry standards and cGMP regulations.
• Ability to apply GMP/GLP regulations and international guidelines to all aspects of the position.
• Able to aseptically gown and work in environmental clean rooms as needed.

Nice-to-haves

• Technical knowledge of biopharmaceutical manufacturing is desirable.
• Proficient knowledge of controlled documentation and data systems.

Benefits

• Opportunities for career growth and development.
• Access to resources and opportunities to make a difference in the world.