Manager QC Raw Materials

Role: Manager of QC Raw Materials overseeing testing programs for GMP manufacturing support. Responsibilities include managing raw material testing aligned with GMP, USP, ICH, EP, JP, and FDA guidelines, providing technical expertise, reviewing and approving test data, managing external testing vendors, and supporting method validation and transfers. The role involves developing and improving raw material qualification strategies, authoring regulatory documentation, and ensuring compliance with current industry standards. Additional duties encompass laboratory management, safety oversight, investigation support, and internal/external audits. Qualifications: Bachelor's or higher in biology, biochemistry, or related field with at least 10 years of cGMP QC experience, including 3+ years in supervisory roles and vendor management. Expertise in compendial testing, analytical methods (HPLC, GC, UV), method validation, and knowledge of GxP, ICH, and FDA guidance is required. Preferred skills include project leadership, strong documentation, organizational abilities, and proficiency in Microsoft Office. HighValue: Industry experience in pharmaceutical QC, GMP compliance, analytical chemistry, regulatory documentation, and vendor oversight. Work setup: primarily office-based with laboratory environment exposure, physical demands include operating lab equipment and computer use.