The Quality Control Supervisor will report to the QC Director.
- Must have understanding and working knowledge with Quality Control principles and concepts such Microbial Assays, Immunoassays, Analytical assays, Water systems, EM programs, etc.
- They will also be responsible for maintaining the day-to-day activities for product manufacture, test and release which include managing analysts’ schedules, instrument calibration, validation, PO generation, managing live testing tracker information, cross-functional daily communication, batch record reviews, document revisions, IOPQ qualification documentation and execution
- This role will also provide extensive support with document writing, document revisions, and handling investigations. Must have thorough understanding of Good Documentation Practices (GDP), identification and review and approval of deviation investigations and Out of Specifications (OOS) results, able to perform root cause analysis and generate corrective actions to improve processes/systems.
- The position will develop Quality Control systems to streamline process and drive efficiencies in support of Microbiological and Analytical methods at the Waltham, MA site.
- This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System