Compliance Coordinator I

4 days ago


Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
Job Summary

The Compliance Coordinator I plays a key role in ensuring the company's manufacturing processes comply with regulatory requirements.

Responsibilities
  • Coordinate batch and formulation record review and corrections to executed records.
  • Initiate new deviations and assist with deviation, CAPA, and change control closure for Manufacturing.
  • Participate in Problem Analysis (PA) events and After Action Reviews (AAR).
  • Schedule and facilitate post-manufacturing campaign lessons learned.
Requirements
  • Bachelor's Degree with two years of experience in pharmaceutical or other regulated industry.
  • Associate's degree and four years of related experience in pharmaceutical or other regulated industry.
Preferred Qualifications
  • Experience with cell culture and purification processes.
  • Experience authoring CAPAs, change controls, and deviations.


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