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QC Supervisor - job post

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  • Fulltime

Volledige vacaturetekst

The QC Supervisor will develop Quality Control Systems to streamline process and drive efficiencies in support of Microbiological and other QC related methods at the Breda, NL site. The QC Supervisor will also be responsible for maintaining the day to day activities for test and release of OPUS pre-packed chromatography columns, including deviation support, OOS support and root cause analysis. The QC Supervisor will report to the QC Director.
As QC Supervisor you will be responsible for the following:
  • Ensure compliance with ISO 9001 regulatory requirements.
  • Manage day to day tasks and responsibilities within the QC group for Endotoxin, Bioburden testing and RODI
  • water testing.
  • Manage the Environmental Monitoring Program and prepare trend reports and provide suggestions for
  • continuous improvement.
  • Monitor Quality metrics for daily tier meetings, Operations meetings and annual management review
  • meetings.
  • Assists with troubleshooting OOS investigations, OOT investigations and NCMR investigations.
  • Review and approval of validation plans/reports, deviations, root cause and corrective action plans prior to
  • implementation.
  • Supervise and mentors direct report(s) which includes setting objectives, monitoring performance and
  • promoting development plans.
  • Support quality audits related to QC activities.
The successful QC Supervisor will meet the following criteria:
  • Bachelor’s degree in Engineering, Biology, Chemistry or related Life Sciences 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.
  • Strong attention to detail.
  • Enthusiastic, collaborative team player, ability to work across all departments to achieve common goals.
  • Experience with LEAN implementation strongly preferred.
  • Demonstrated ability to foster a Quality Culture across the organization
What Repligen Offers:
Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, fast-paced environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Breda, Netherlands.
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