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Compliance Quality Specialist

3 months ago

Fredericton, New Brunswick, Canada Artech LLC Full time
Quality Assurance Analyst

The Quality Assurance Analyst will oversee the Contract Manufacturing Organization (CMO) in critical areas such as change control, deviation tracking, and the preparation of Annual Product Quality reports. This position entails reviewing Batch Production Records, supporting Document Management, and ensuring readiness for audits and inspections. The ideal candidate should possess a Bachelor’s degree in Life Sciences along with over five years of experience in the pharmaceutical or biotechnology sectors. Exceptional communication skills and meticulous attention to detail are vital for success in this position.

Key Responsibilities:
  • Supervise CMO Batch Production Records
  • Support Document Management and various QA activities
  • Coordinate and evaluate manufacturing documentation at the CMO facility
  • Prepare for inspections and audits by regulatory bodies
  • Ensure adherence to Quality standards
  • Address and escalate significant quality concerns
Required Qualifications:
  • Bachelor’s degree in Life Sciences or a related field
  • Over five years of experience in the pharmaceutical or biotechnology industry
  • Familiarity with cGMP Quality, Quality Systems, and regulatory requirements
  • Excellent communication and organizational abilities
  • Detail-oriented with a keen ability to identify discrepancies