Principal Analytical QA Specialist, Drug Substance

Responsibilities: Provide Quality Assurance oversight for GMP manufacturing, release, and stability activities for veterinary pharmaceutical products. Manage batch disposition and quality events while collaborating with CDMOs and regulatory affairs to ensure compliance with cGMP and VICH guidelines.

Requirements: Requires a B.S./M.S. in a scientific discipline with at least 12 years of pharmaceutical industry experience, including 6 years in GxP QA roles. Must have strong knowledge of FDA CVM regulations and experience managing external manufacturing partners.

Key skills: Quality Assurance, GMP Manufacturing, Analytical Method Validation, Batch Disposition, CDMO Management, Regulatory Compliance, Stability Programs, Root Cause Analysis, CAPA, Data Integrity, Risk Management, Technical Writing, Project Management, Cross-functional Collaboration, Audit Programs, Quality Systems

Keywords: cGMP, VICH, FDA CVM, API, Drug Substance, Drug Product, CTD Module 3, OOS, OOT, CAPA, Change Control, Annual Product Review, Field Alert Report, Small Molecule, Solid Oral Dosage, RAC, ASQ, Google Workspace, eQMS, Quality Management Systems, Pharmaceuticals, Veterinary Medicine, Clinical Development, Validation Protocols, Stability-Indicating Methods