Manufacturing Compliance Specialist

6 days ago

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

The Senior Compliance Specialist, Manufacturing will be responsible for ensuring compliance with regulatory requirements and company policies in the manufacturing department. This includes leading deviation investigations, change controls, and CAPAs, as well as supporting internal and external audits.

Key Responsibilities
  • Compliance
    • Lead deviation, CAPA, and change control closure for Manufacturing
    • Leads review of quality events and initiation of new deviations, as required
    • Lead initiation of New Product Introduction change controls
    • Lead Root Cause Analysis Investigations
    • Lead Problem Analysis (PA) events
    • Lead After Action Reviews (AAR)
    • Lead the completion of Periodic Reviews
    • Lead Internal and External Audit readiness, coordination, and response.
  • Deviation Investigation
    • Participate and support investigations for deviations and events.
    • Participate in investigations and assist in identification of root and/or contributing causes.
    • Ensures required Management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders.
    • Support client due diligence and Quality audits as well as regulatory inspections.
    • Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • Equipment Compliance Coordination
    • Is the Primary Point of Contact for any equipment related servicing and or Out of Service requests.
    • Ensures all equipment is scheduled for routine maintenance and calibration and provide metrics for executed work.
    • Work directly with the Facilities group to plan and support any on-site vendor support/maintenance activities including escorting on-site visitor requirements ensuring all visitors are registered for proper access on the equipment.
    • Ensure all equipment utilized on the floor for manufacturing execution is entered correctly into the Building Management System and has accurate and effective preventative maintenance activities.
    • Point of contact for client and regulatory inspection support with trends and metrics for all manufacturing equipment with respect to maintenance and life-cycle.
    • Maintains the schedule for planned down-time for all manufacturing equipment and provides metrics for equipment up/down time.
    • Leads the facility shutdown planning and associated change controls with respect to manufacturing equipment and facilities and provides metrics for all facility related change controls.
    • Leads the Production Floor GEMBA walks to identify any issues/problems that need addressing to remain in compliance and provides metrics for common themes and any trends that may occur.
    • Ensures routine walk throughs of the facility are completed and work orders for items found have been submitted. Also provides metrics for items found to identify and trends that may occur.
Requirements
  • Bachelors Degree and five (5) years experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; OR
  • Associate degree and seven (7) years experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; OR
  • High School Diploma or GED and nine (9) years experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.
Preferred Qualifications
  • Experience with cell culture and purification processes
  • Experience leading teams

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