Principle Quality Assurance Specialist

1 month ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
Job Summary

AGC Biologics is seeking an experienced QA Scientist to join our team in Copenhagen. The successful candidate will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.

Key Responsibilities
  • Close collaboration with internal stakeholders
  • Change control, deviation handling, and CAPAs
  • Review and approval of material specifications
  • Release of raw materials and disposables
Requirements
  • 3+ years of experience with Quality Assurance and/or material management
  • Relevant academic background within pharmacy, biotechnology, biology, chemistry, or similar
  • Proven experience in QA and/or material management
  • Requirements for commercial and/or late-stage clinical phase GMP manufacturing of biological intermediates, APIs, and Cell Banks
  • QA oversight and guidance of staff
  • Experience with contract manufacturing and business understanding
  • Deviation handling, including root cause investigations
  • Review and evaluation of cGMP documentation
About AGC Biologics

AGC Biologics is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy, and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). We are committed to delivering high-quality products and services to our customers.



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