Scientist, QA Manufacturing Support Specialist

1 month ago


Copenhagen, Copenhagen, Denmark AGC Inc Full time
Scientist, QA Manufacturing Support

Job Summary: We are seeking a highly skilled Scientist, QA Manufacturing Support to join our team at AGC Biologics. As a key member of our Quality Assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing operations.

Key Responsibilities:

  • Provide quality support to manufacturing operations, ensuring compliance with procedures and GMP requirements.
  • Review and approve manufacturing records and logbooks in real-time.
  • Collaborate with manufacturing teams to resolve quality-related issues.
  • Conduct batch record reviews and approvals as part of the batch release process.
  • Participate in Gemba walks and conduct site systems audits to ensure compliance.
  • Review and approve validation and qualification documentation.
  • Support manufacturing teams in driving improvements in GMP compliance.
  • Perform quality reviews and approvals of deviations, change controls, and CAPAs.

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.
  • Previous biopharma experience is preferred but not required.
  • Strong working knowledge of GMP principles and guidelines.
  • Excellent written and verbal communication skills.
  • Ability to work in a fast-paced, matrix environment.

About AGC Biologics:

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA, messenger RNA, viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan.

What We Offer:

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. We are an equal opportunity employer and welcome applications from diverse candidates.



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