Associate Principal Scientist, Quality Assurance Specialist

4 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
Job Title: Associate Principal Scientist, Quality Assurance

We are seeking an experienced Quality Assurance professional to join our team at AGC Biologics. As an Associate Principal Scientist, Quality Assurance, you will play a key role in ensuring the quality of our biologics manufacturing processes and products.

Key Responsibilities:
  • Support Supply Chain, Process Transfer, and QC for late stage and commercial products
  • Collaborate with internal stakeholders to ensure effective quality-related activities
  • Review and approval of material specifications
  • Release of raw materials and disposables
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
  • 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
What We Offer:

AGC Biologics offers a dynamic working environment with opportunities for professional growth and development. You will work with a talented team of professionals who are passionate about delivering high-quality products and services. We offer a competitive salary and benefits package, as well as opportunities for career advancement.

As a Quality Assurance professional at AGC Biologics, you will have the opportunity to work on a wide range of projects and contribute to the development of our quality management system. You will be part of a team that is dedicated to ensuring the quality and safety of our products, and you will have the opportunity to make a real difference in the lives of patients around the world.

We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced Quality Assurance professional looking for a new challenge, we encourage you to apply for this exciting opportunity.



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