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FSP - QC Reviewer - Biologics Data Review

Thermo Fisher Scientific

Thermo Fisher Scientific seeks a QC Reviewer for data review activities supporting biologics product development. This onsite Foster City position involves reviewing analytical data and documentation for compliance with GMP standards, data integrity principles, and quality systems across product release, stability, and regulatory activities.

Responsibilities

  • Perform data review and reporting for product release, stability, qualification, and validation activities
  • Identify and escalate data discrepancies, documentation issues, and data integrity concerns
  • Verify QC data for accuracy, completeness, and compliance with records requirements
  • Support regulatory submissions, inspections, and health authority responses with technical assessments
  • Participate in deviation investigations, CAPAs, and continuous improvement efforts

Requirements

  • Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or Chemical Engineering
  • 2-5 years of relevant experience in quality control or analytical data review
  • Working knowledge of GMP requirements and data integrity principles
  • Ability to identify trends and escalate data discrepancies and documentation issues
  • Legal authorization to work in the United States without sponsorship
  • Ability to pass comprehensive background check including drug screening
Vacancy posted 2 days ago
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