Scientist, QA Manufacturing Support Specialist

4 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

Our mission is to work side by side with our customers to improve patients' lives by bringing new biopharmaceuticals to market.

The QA Manufacturing Support Scientist plays a crucial role in ensuring manufacturing compliance with applicable procedures and GMP requirements.

Key Responsibilities:

  • Provide real-time quality support to manufacturing operations, ensuring adherence to procedures and GMP requirements.
  • Review and approve manufacturing records and logbooks, identifying and resolving any issues.
  • Collaborate with manufacturing operations to drive improvements in GMP compliance across all shifts.
  • Support manufacturing during batch review, ensuring Good Documentation Practice.
  • Perform quality review and approval of deviations, change controls, and CAPAs.
  • Review and approve buffer and media MPRs.

Requirements:

  • Bachelor's and/or Master's degree in Natural Sciences.
  • Alternatively, certified laboratory technician with a degree in laboratory science, biotechnology, or medical laboratory technology, with 3-5 years of experience in a GMP environment.
  • Experience with BPR/MPR review is a plus.
  • Strong working knowledge of GMP principles and guidelines.
  • Excellent written and verbal communication skills.
  • Ability to work in a fast-paced, matrix environment.

Location: Copenhagen Site



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