This role is responsible for supporting the core quality systems, including investigation/deviation management, general and internal audit CAPA tracking, change control, risk management, compiling, trending and reporting key quality metrics for Senior Management review, tracking internal audit CAPAs, and other quality system functions, as needed. Works in a fast-paced environment supporting the quality assurance/quality control departments of a CMO for Phase I/II GMP manufacturing of biologic bulk drug substance and sterile finished drug product.
Administer Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
Skills & Technical Expertise:
Measurement of Performance: