Manufacturing Compliance Coordinator II

1 month ago


College Station, Texas, United States FUJIFILM Corporation Full time
Job Summary

The Manufacturing Compliance Coordinator II plays a crucial role in ensuring the quality and compliance of our manufacturing processes. This position is responsible for tracking, coordinating, and closing Manufacturing CAPAs, change controls, and deviations, as well as supporting the timely release and disposition of batches and other post-execution activities.

Key Responsibilities
  • Collaborate with site management to instill a Quality Culture by coaching Manufacturing staff in the application of GMP Principles.
  • Support the Quality and Manufacturing organization during internal and supplier audits.
  • Assist in implementing quality systems that enable cGMP manufacturing of pre-clinical to commercial products.
  • Coordinate batch and formulation record review and corrections to executed records.
  • Lead deviation, CAPA, and change control closure for Manufacturing, including initiation of New Product Introduction change controls.
  • Assist with leading Root Cause Analysis Investigations.
  • Support the completion of periodic reviews and provide metrics around batch closure.
Requirements
  • Bachelor's Degree and four (4) years experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.
  • Excellent oral and written communication skills, interpersonal and organizational skills.
  • Practical understanding of equipment used in bioprocessing (downstream and/or upstream).
  • Proficient with Microsoft Office applications.
  • Ability to multitask and easily prioritize work.
  • Experience working in cleanroom environments.
Preferred Qualifications
  • Experience with cell culture and purification processes.
  • Experience authoring CAPAs, change controls, and deviations.
About FUJIFILM Corporation

FUJIFILM Corporation is a global leader in the development and manufacturing of innovative technologies. We are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. We are an equal opportunity and affirmative action employer, and we welcome applications from diverse candidates.



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