FSP – QC Reviewer – Data Review

Job Description

• Fully onsite, full-time QC Reviewer – Data Review role in Foster City, CA, supporting biologics products in a laboratory and contract research environment.
• Review and verify QC analytical data and documentation for product release, stability, method qualification, method transfer, validation, and regulatory activities.
• Identify trends, discrepancies, documentation issues, and potential data integrity concerns; support deviations, investigations, CAPAs, metrics, and continuous improvement.
• Support regulatory submissions, inspections, health authority responses, technical assessments, and preparation of supporting documentation while maintaining GMP, data integrity, and quality-system compliance.
• Requires a Bachelor’s degree in a relevant laboratory science and comparable to 2–5 years of related experience; legal US work authorization without sponsorship and successful background check with drug screening are required.