Senior Quality Assurance Specialist

2 weeks ago


Somerset, United States On-Board Companies Full time
Job Summary

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at On-Board Companies. This role will be responsible for ensuring the quality and integrity of our manufacturing processes, including Change Control and CAPA systems.

Key Responsibilities
  • Review and oversee all Change Control and CAPA proposals to ensure timely and controlled implementation.
  • Support policies and procedures for Change Control and CAPA systems consistent with FDA regulations and corporate requirements.
  • Collaborate with cross-functional teams to ensure changes are reviewed and approved.
  • Develop and monitor site metrics and reports for Change Controls and CAPAs.
Requirements
  • Minimum Bachelor's Degree in a scientific or technical field.
  • 3+ years' experience in Quality Assurance, with cross-functional experience in Engineering, Technical Operations, Regulatory Affairs, or Laboratory.
  • Working knowledge of FDA and applicable non-US regulations, guidance, and industry standards.
  • Experience with electronic Quality Management Systems, ERP systems, and MS Office applications.


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