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Senior Compliance Specialist

2 months ago

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

We are seeking a highly skilled Senior Compliance Specialist to join our team at FUJIFILM Holdings America Corporation. This role will be responsible for ensuring compliance with regulatory requirements and industry standards in our manufacturing operations.

Key Responsibilities
  • Lead deviation, CAPA, and change control closure for Manufacturing
  • Review quality events and initiate new deviations as required
  • Initiate New Product Introduction change controls
  • Conduct Root Cause Analysis Investigations
  • Lead Problem Analysis (PA) events
  • Lead After Action Reviews (AAR)
  • Complete Periodic Reviews
  • Lead Internal and External Audit readiness, coordination, and response
  • Support Compliance Coordinators with batch and formulation record review and corrections
  • Support Compliance Coordinators with continuous improvement of batch-related documentation
  • Coordinate deviation workload within the Manufacturing Compliance Coordination group
  • Generate and maintain metrics around batch closure, including deviation, CAPA, and change control status
  • Support Compliance Coordinators to achieve 100% on-time closure of all quality-related investigations
  • Provide training and support to Compliance Coordinators and Deviation Coordinators
Requirements
  • Bachelor's Degree and five (5) years of experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role
  • Associate degree and seven (7) years of experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role
  • High School Diploma or GED and nine (9) years of 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
Working Conditions and Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders, and stretching
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment
  • Lift up to 25 pounds frequently and up to 50 pounds, on occasion