Senior Compliance Specialist

6 hours ago


TX United States Fujifilm Full time
Job Title: Senior Compliance Specialist - Manufacturing

Fujifilm Diosynth Biotechnologies is seeking a highly skilled Senior Compliance Specialist to join our team in College Station, Texas. As a key member of our Manufacturing Compliance team, you will be responsible for ensuring compliance with regulatory requirements and industry standards in our biopharmaceutical 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
  • Lead 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:
  • Working knowledge of cGMP regulations associated with production of biologic drug products
  • Excellent oral and written communication skills, interpersonal, and organizational skills
  • Excellent organizational, analytical, data review, and report writing skills
  • Thorough understanding of all aspects related to cGMP manufacturing
  • Thorough understanding of Single-Use Technology used in bioprocessing (downstream and/or upstream)
  • Thorough understanding of closure requirements associated with working in a 'Ballroom' manufacturing facility
  • Proficient user of deviation management systems such as TrackWise
  • Proficient user of quality document control systems such as MasterControl
  • Proficient with Microsoft Office applications
  • Good self-discipline and attention to detail
  • Flexible work hours, willing to work outside of normally scheduled hours as necessary
  • Ability to multitask and easily prioritize work
  • Ability to work independently with little supervision
  • Good planning skills and willingness to interface with colleagues across all levels of the FDB network
Working Conditions & Physical Requirements:
  • 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
Qualifications:
  • Bachelor's Degree and five (5) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role
  • Associate degree and seven (7) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role
  • High School Diploma or GED and nine (9) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role


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