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Quality Engineer III

Thermo Fisher Scientific · St. Louis, MO

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Role summary

Quality Engineer III supports quality assurance for clinical and commercial manufacturing programs at a regulated pharmaceutical environment. The role involves investigating quality events, ensuring GMP compliance, and driving continuous improvement across cross-functional teams.

What they're looking for

  • Bachelor's degree in Engineering, Life Sciences, Chemistry, or related scientific discipline
  • Advanced degree with 3+ years QA experience, or bachelor's with 5+ years in regulated manufacturing
  • Demonstrated experience with GMP quality systems and regulatory compliance
  • Working knowledge of FDA, EMA, ICH, GMP regulations and requirements
  • Strong analytical skills, root cause problem-solving, and attention to detail
  • ASQ CQE, CQA, or equivalent quality certification (preferred)
  • Experience with biologics manufacturing or process validation (preferred)

What you'll be doing

  • Support quality assurance activities for clinical and commercial manufacturing programs
  • Review and approve GMP documentation including batch records, deviations, and CAPA submissions
  • Lead quality investigations, perform root cause analyses, and implement corrective actions
  • Evaluate quality data and metrics to identify trends and recommend process improvements
  • Participate in internal audits, customer audits, and regulatory inspections

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RoleLantern checked active
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Date posted14 days ago
Last source check1 day ago
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