Biotechnology Quality Assurance Specialist

3 days ago


St Louis, Missouri, United States Thermo Fisher Scientific Full time

**About the Role**

We are seeking a highly skilled Biotechnology Quality Assurance Specialist to join our team at Thermo Fisher Scientific in St. Louis, MO.

The estimated salary for this position is $85,000 - $110,000 per year, depending on experience.

About the Company

Thermo Fisher Scientific is a global leader in serving science, enabling our customers to make the world healthier, cleaner, and safer.

We are dedicated to delivering exceptional products and services to support scientific research and discovery.

Job Description

This non-supervisory role will work closely with the Supervisor of QA Operations to ensure the quality and compliance of our biologic drug substance manufacturing facility.

You will spend most of your work hours in manufacturing areas, supporting active processing and working closely with Manufacturing and Process Engineering to supervise activities from a quality perspective.

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 Fit and Finish, Changeover, and Change Control procedures and practices

Requirements

  • Bachelor's Degree (BA/BS) in Life Sciences, 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


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