Senior Associate Scientist, External Quality Analytical Oversight

Senior Associate Scientist role supporting external quality control oversight across Gilead's commercial manufacturing network. Responsibilities include review of contract laboratory data, LIMS verification, documentation management, and continuous improvement of QC processes to ensure global cGMP compliance.

Responsibilities

• Review external QC laboratory data including Certificates of Analysis and stability reports for commercial release
• Verify contract testing laboratory raw data accuracy including method conditions, calculations, and system suitability
• Use LIMS to transcribe and verify results, complete test authorizations, and generate CoAs and reports
• Identify and escalate data integrity concerns, atypical results, and coordinate laboratory investigations
• Contribute to process improvement by authoring SOPs and supporting system changes

Requirements

• BS in Chemistry, Biochemistry, or related field with 5+ years experience, or MS with 3+ years experience
• Commercial quality control knowledge and experience
• Understanding of GMP principles and data integrity standards
• Ability to manage and influence testing at contract laboratory facilities
• Critical thinking, analytical skills, and independent work capability
• Strong organizational skills and attention to detail
• Effective verbal and written communication