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AGC Biologics

End-to-end biopharma CDMO for gene therapies

Quality Assurance Operations Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeHeidelberg, Germany

About the Job

Requirements

  • A university degree in a natural science, such as biotechnology, pharmacy, chemistry, or a similar field.
  • QA experience in a pharmaceutical or biotechnology company, especially handling deviations, CAPAs, and change control, is desirable.
  • Experience with TrackWise, Microsoft Office, and databases is desirable.
  • Willingness to work shifts, including early and late shifts, and weekends.
  • Very good spoken and written German and English skills.

Responsibilities

  • Ensure GMP compliance in production, quality control, and release of active substances manufactured at the site, including regular walkthroughs in production, laboratories, and warehouses as QA on the shop floor.
  • Review batch records and prepare batch release by checking batch documentation, analysis protocols, and certificates of analysis for completeness, plausibility, formal correctness, and compliance with regulatory requirements; support the Qualified Person with batch release.
  • Process deviations, out-of-specification cases, and change-control procedures, including CAPA follow-up.

About the Company

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AGC Biologics

End-to-end biopharma CDMO for gene therapies

AGC Biologics is a global contract development and manufacturing organization (CDMO) that develops and manufactures biopharmaceuticals, including therapeutic proteins, plasmid DNA, viral vectors, and cell therapies. It offers end-to-end services from early development through commercial-scale manufacturing, with fast-track options for orphan drugs and rare diseases. The company runs cGMP-compliant facilities across the US, Europe, and Asia, recently expanding with a Longmont, Colorado site focused on cell and gene therapies. Its goal is to help biopharma partners bring new treatments to market efficiently and safely by providing integrated development and manufacturing, supported by its international footprint and project acceleration capabilities.

Company size
1,001-5,000
Company stage
Acquired
Total funding
$557.7M
Headquarters
Bothell, WA
Founded
2001

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