Job Description
Execute Quality disposition (approval or rejection) of bulk drug substances. Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations. Ensure that deviations from established procedures are identified, reported, and documented per procedures. Ensure that changes that could potentially impact drug substance quality are assessed according to procedures. Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements. Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations. Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and superv...