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Biogen

Sr Associate I, Quality Assurance Operations

Biogen

Research Triangle Park, NC · full time · Mid

$81,000 – $105,000

Listed on Biogen’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

A quality assurance professional overseeing compliance and operations at a biotech manufacturing facility, reviewing batch records, conducting investigations, and coaching teams to maintain GMP standards. This role suits someone with pharma QA experience who wants to deepen their expertise while mentoring others.

Our summary, not Biogen’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • Bachelor's degree (preferably in life sciences)
  • Minimum 4 years of quality assurance experience in GMP pharmaceutical or biotech manufacturing
  • Experience reviewing and approving batch records
  • Experience conducting investigations and presenting findings to quality management and regulatory bodies
  • Advanced understanding of global quality systems and GxP regulations
  • Ability to work independently and collaboratively across organizational levels

Nice to have

  • Drug substance manufacturing experience
  • Biologics experience
  • Contract manufacturing organization experience
  • Product disposition support experience
  • Experience explaining investigations to regulatory bodies

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