Senior Quality Specialist, Technical

Role: Senior Specialist, Quality Assurance Technical, supporting qualification and validation activities for solid oral and biologic products, ensuring compliance with regulatory standards. 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.