Senior Quality Assurance Specialist, Biologics Manufacturing

11 hours ago


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

We are seeking an experienced Senior Quality Assurance Specialist to support our biologics manufacturing operations.

Key Responsibilities
  • Collaborate closely with internal stakeholders to ensure effective quality management.
  • Support Supply Chain, Process Transfer, and QC for late stage and commercial products.
  • Review and approve material specifications, and release raw materials and disposables.
  • Participate in deviation handling, CAPAs, and change control.
Requirements
  • 3+ years of experience in Quality Assurance and/or material management.
  • Relevant academic background in pharmacy, biotechnology, biology, chemistry, or similar.
  • Proven experience in QA and/or Material Management.
  • Experience with contract manufacturing and business understanding.
  • Deviation handling, including root cause investigations.
  • Review and evaluation of cGMP documentation.
What We Offer
  • A dynamic working place with varied tasks and challenges.
  • Opportunities to work with international customers and interact with various departments.
  • Exciting and challenging assignments.
  • Flexible work environment with a focus on teamwork and collaboration.

AGC Biologics is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy, and the USA. Our team provides comprehensive biologics manufacturing services from DNA to active pharmaceutical ingredient (API). Visit our website to learn more about our company.



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