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QA Engineer II

2 months ago

St Louis, United States Thermo Fisher Scientific Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific team, discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career with us

Location/Division Specific Information

St. Louis, MO / Drug Substance Division - The Drug Substance Division is one of the five divisions that make up the Pharma Services Group. We specialize in both development and commercial drug substance services. This allows us to serve the needs of Small/Emerging, Mid-Sized, and Large Pharma sectors globally.

How will you make an impact?

A QA Engineer II is a Quality Assurance professional responsible for problem resolution on and off the Quality Control and Manufacturing floor and quality oversight of pharmaceutical production.

Routine Tasks

  • Coordinate and ensure the successful day-to-day oversite of contract manufactured biologic molecule(s).

  • 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, but not limited to, Batch Records, Standard Operation Procedures/Controlled Documents, Technical Transfer Protocols, Deviations, CAPAs, Change Controls, and other Quality Records.

  • Assisting 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.

How will you get here?

Education

Bachelor’s Degree in biology, biochemistry, chemistry or other science related field preferred or equivalent experience in leu of education requirements. Non-science degrees will be considered with appropriate experience.

Experience

3+ years of experience in a GMP Environment. 1-3 years of experience within a professional level Quality Assurance, Quality Operations, or Compliance preferred. Experience with SAP, TrackWise, and/or Documentum is suggested

Knowledge and Skills

  • Knowledge of industry standards and cGMP regulations.

  • Preferred knowledgeable of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals

  • 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

  • Decision Making and Leadership Skills

  • Technical knowledge of biopharmaceutical manufacturing is desirable

Abilities

Able to complete job functions under minimum guidance from other Quality personnel. Ability to work 8-hour fixed schedule onsite with possible weekend work or on call coverage. Physical: Regularly required to talk and hear. The employee may be required to stand and/or walk for extended periods. The employee is also required to sit, use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

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.