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Manufacturing QA Associate (2nd Shift)

Eurofins · Sanford, NC

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Role summary

Eurofins seeks a Manufacturing QA Associate for second shift operations at a drug substance facility in Sanford, NC. The role involves real-time quality oversight of manufacturing documentation, GMP compliance monitoring, batch record review, and deviation management to ensure regulatory adherence.

What they're looking for

  • Bachelor's degree in microbiology, chemistry, biological sciences, or bioengineering
  • 2-4 years relevant QA experience in GMP drug substance manufacturing, or Master's degree with up to 2 years experience
  • Batch record review and housekeeping monitoring experience
  • Proficiency with deviation reports, change controls, CAPA, and analytical data interpretation
  • Data integrity knowledge and GMP regulatory experience or demonstrated ability to develop proficiency
  • Knowledge of ICH Q7 and 21 CFR 211 regulations

What you'll be doing

  • Conduct real-time review of batch and manufacturing documentation for errors and compliance issues
  • Perform GMP walkthroughs and housekeeping inspections throughout facility
  • Initiate and assist in deviation investigations and room/line clearances
  • Review and approve analytical testing results and support initial investigations on manufacturing floor
  • Collaborate cross-functionally to maintain compliance and meet operational timelines

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