Quality Assurance Specialist
4 weeks ago
Quality Assurance Specialist
About the Role:This is a non-supervisory role, working with the Supervisor of QA Operations at the Thermo Fisher St. Louis site. The Quality Assurance Specialist will be responsible for ensuring compliance with industry standards and regulations in preparation for internal quality audits, client audits, and regulatory inspections.
Key Responsibilities:- Conduct thorough audits and inspections to ensure sustained compliance with industry standards and regulations
- Collaborate with multi-functional teams to develop, optimize, and improve processes to enhance efficiency, productivity, and quality
- Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross-contamination
- Participate in client and regulatory audits as a SME on the Fit and Finish, Changeover, and Change Control procedures and practices
- Bachelor's Degree (BA/BS) in Life Sciences (biology, chemistry, biochemistry), Engineering, or another science related field combined with a minimum of three (3) years of relevant experience
- Experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred
- Cleanroom manufacturing experience is highly preferred along with a comfort level with full ISO 5 and ISO 7 gowning requirements
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
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