Senior Quality Specialist, Technical

Responsibilities: review and approve technical documents such as validation protocols, change controls, investigations, and stability reports support data review and regulatory discrepancy checks develop knowledge of validation requirements, manufacturing, and analytical testing assist with technical projects and cross-functional collaboration

Requirements: Bachelor's in life sciences (Chemistry, Biology, Chemical Engineering preferred) 5+ years in GMP Quality Assurance, Validation/Qualification in biotech/pharma familiarity with electronic QMS systems like Veeva broad knowledge of cGMPs (CFR/ICH) and international guidelines High-Value:solid oral and biologic products, GMP validation, technical documentation review, supplier change management, stability, and investigations. WorkSetup:remote in San Diego with 10% domestic and international travel; face-to-face work expected.