Engineer II, QA

Thermo Fisher Scientific - Saint Louis, MO

Full-time - Mid Level

Saint Louis, MO

Computer and Electronic Product Manufacturing

About the position

The QA Engineer II at Thermo Fisher Scientific is responsible for ensuring quality oversight in pharmaceutical production, focusing on problem resolution both on the Quality Control and Manufacturing floor. This role involves coordinating daily operations of contract manufactured biologic molecules, reviewing GMP documents, and participating in site inspections and meetings to maintain compliance with industry standards and regulations.

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 as needed.
• Perform review and approval of GMP documents including 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.
• Conduct routine quality walk-throughs of assigned production and support areas.
• Participate in site inspection readiness activities, inspections, 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

• Knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
• Technical knowledge of biopharmaceutical manufacturing is desirable.