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FSP - QC Reviewer

$67.7k - $80k

Thermo Fisher Scientific

Quality control reviewer position within Thermo Fisher Scientific's Analytical Services team. The role involves reviewing laboratory data, verifying numerical results for regulatory submissions, and ensuring compliance with analytical methods and standard operating procedures at a pharmaceutical client site in Foster City, California.

Responsibilities

  • Review raw laboratory data and verify numerical information for regulatory filings
  • Evaluate laboratory results for compliance with analytical methods and SOPs; identify and document deficiencies
  • Author clinical and commercial stability protocols; transcribe and review SOPs
  • Consolidate data for QC metrics and prepare QC statements noting analytical data discrepancies
  • Train new QC reviewers and laboratory staff; communicate with lab personnel regarding documentation quality

Requirements

  • Bachelor's degree in Chemistry, Biochemistry, Biology, Molecular Biology, or similar lab science field
  • 2+ years relevant experience OR Master's degree in related discipline
  • Knowledge of GLP, GMP, and Federal Regulations
  • Strong technical knowledge of laboratory procedures and chromatography methods
  • Excellent verbal and written communication skills
  • Strong attention to detail and ability to independently review analytical reports

Compensation: $67,699–$80,000 base, plus variable annual bonus and comprehensive benefits package

Vacancy posted a month ago
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