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Thermo Fisher Scientific Quality Engineer II in Saint Louis, Missouri

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .

Engineer II QA

This is a non-supervisory role, reporting to the Supervisor of QA Operations, which is a sub-group within the Quality Unit.

A QA Engineer II is a QA professional that provides leadership and experience with introduction of new client molecular entities. Performs client quality project management, assisting the client in Quality needs and understanding of Quality guidelines and Regulations, ensures commitments and adherence to Quality Agreements. A QA Engineer II is a recognized subject matter expert in one or more of the following Quality Assurance areas: cGMP compliance, GLP, biopharmaceuticals manufacturing, and/or regulatory affairs, as warranted to each specific program.

A QA Engineer II is responsible for, but not limited to, batch record review, disposition of product, change control approval and ensuring alignment of the Clinical and Commercial Ops program with respect to phase appropriate requirements and strategies. Personnel are responsible for adhering to GMP standards of job performance including ensuring that training is current in all aspects. Personnel are expected to take the initiative to improve the quality of operations and to improve and maintain a quality culture with a goal of consistency.

Location/Division Specific Information

Patheon, Bio services Division, St. Louis, MO

How will you make an impact?

Provides leadership to assigned staff by performing the following: developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

What will you do?

Oversees and ensures the successful day-to-day oversite of contract manufactured biologic molecule(s).

  • Responsible for completing training tasks based upon a monitored curriculum.

  • Provide guidance and information from a quality perspective and need to Clients to help drive the program towards successful outcomes.

  • Act as Liaison between the Client and sub-groups of Quality Assurance during technology transfer of new products; ensuring development of process adheres to applicable regulations based on phase appropriate FDA, EMA and ICH guidelines. Oversight to include work from Process Development to Process Validation

  • Monitors for quality related issues and coordinates resolutions.

  • Review and aid in the establishments and maintenance of Client Quality Agreements

  • Review and Approval of GMP documents such as, but not limited to, Batch Records, Standard Operation Procedures, Technical Transfer Protocols, Deviations and Change Controls.

  • Contribute to continual process improvement by participating in meetings, seminars, and site projects

  • Participates in Client audits. Coordinates with PM on client communications. Attend customer Face to Face meetings and weekly meetings as needed.

How will you get here?

  • BS/ BA in biology, biochemistry, chemistry or other science related field

  • 5 + years within a GMP Environment

  • 2 + years of experience within a Quality Role

  • Proficient with computers (MS Office). Working knowledge of controlled documentation and data systems.

  • In depth knowledge of cGMP regulations.

Knowledge, Skills, Abilities

  • 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.

  • Demonstrated ability to make key decisions.

  • Technical writing skills.

  • Technical knowledge of biopharmaceutical manufacturing is desirable.

  • Microsoft Project/Project Management is desirable.

  • Ability to aseptically gown and/or sterile gown as needed

  • Ability to work within environmental clean rooms

  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.