Overview
Make a global impact—join Repligen. We’re united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success—where every voice matters and every contribution drives progress. Join us! The QC Supervisor will develop Quality Control/Incoming Inspection to streamline process and drive efficiencies in support of Microbiological, other QC related methods and Incoming material release testing. The QC Supervisor will be responsible for maintaining the day to day activities for test and release of materials including deviation (non-conformances, OOS etc). |
Responsibilities
The successful candidate will be responsible to provide Quality Control support to ensure the supply of high-quality product to our customers. To accomplish this the following is required: - Maintain compliance to ISO9001.
- Lead and support investigations for deviations (e.g. Non-conforming Materials, Microbial Contamination events).
- Participates in Quality Controle daily routines and training initiatives.
- Maintain the Environmental/RODI water monitoring program including trending reports.
- Monitor and Compile Quality metrics for daily tier meeting, operational meetings and management review meetings.
- Review and approval of validation plans (method validation), deviations and non-conformances.
- Supervise and mentor direct reports which includes setting objectives, monitoring performance and promoting development plans.
- Support during Internal/External audits.
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Qualifications
- Bachelor's Degree in (Micro)Biology or equivalent.
- Minimum of 5-7 years of experience in Quality Control in an ISO 9001 certified Quality Management System or equivalent.
- Enthusiastic team player who is collaborative across all departments.
- Experience with LEAN implementations is strongly preferred.
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