Overview
- 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
- This is a full-time on-site role in Waltham, MA with some flexibility.
Responsibilities
- Ensure compliance with ISO 9001 regulatory requirements
- Participates in Quality Control daily routines and training initiatives
- Complete management of day-to-day analyst schedules and product testing and release requirements for the OPUS product line
- Develop, Monitor and Compile Quality metrics for daily tier meetings, Operations meetings and annual management review meetings.
- Review and approval of validation plans/reports, deviations, root cause and corrective action plans prior to implementation.
- Assists with troubleshooting OOS investigations, OOT investigations and NCMR investigations.
- Supervise and mentors direct report(s) which includes setting objectives, monitoring performance and promoting development plans.
- Support Customer Audits related to all QC Activities.
Qualifications
- Bachelor’s degree in Engineering, Biology or Chemistry degree required.
- Minimum of 5-7 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required. Microbiology experience required.
- Knowledge and experience with USP Methods and the ability to apply updates as required.
- Minimum 0-2 years of experience mentoring other QC staff.
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