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Associate III, Quality Control Chemistry

$69k - $90k

Biogen Inc

Biogen seeks a Quality Control Associate III to support QC Chemistry operations in Research Triangle Park, ensuring cGMP compliance and conducting release and stability testing for clinical and commercial products. The role involves technical leadership, investigations, and cross-departmental collaboration within the quality assurance function.

Responsibilities

  • Perform release and stability testing and conduct technical review of QC Chemistry data and documentation
  • Author or review investigational protocols, reports, change control requests, and validation documentation
  • Support analytical method transfer, qualification, development, and validation in collaboration with technology teams
  • Provide technical leadership on laboratory investigations and coordinate test results with chemistry customers
  • Lead or participate in cross-functional site teams and mentor peer associates

Requirements

  • Bachelor's degree in chemistry, biology, or life sciences; or Associate's degree plus 2+ years lab experience
  • HPLC experience and technical knowledge of QC chemistry release and stability methodology
  • Demonstrated instrument and method troubleshooting skills
  • Knowledge of FDA and EMEA regulations and compliance requirements
  • Prior GMP experience in quality control chemistry preferred
  • Experience with LC-MS, dissolution, Karl Fischer, or GC preferred

Compensation: $69,000–$90,000 base

Vacancy posted a month ago
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