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Scientist, Quality Control Specialist

2 months ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

The Role

You will be part of the QC Stability Team, a key component of Quality Control, responsible for handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your day-to-day work will involve close collaborations with stakeholders such as customers, project managers, management, your own department, and QA.

Your key responsibilities will include:

  • Developing and reviewing CR, Deviations, and CAPA documents
  • Creating and reviewing customer-specific stability protocols and reports
  • Engaging with customers on stability-related topics
  • Overseeing testing at external laboratories
  • Ensuring cGMP compliance with relevant guidelines (EU, FDA)

The Department

You will be part of QC Support in the QC laboratory, joining a team of highly dedicated scientists and technicians. QC Support consists of three departments: QC Raw materials, QC Samples & Service, and QC Stability.

The Ideal Candidate

We are looking for an MSc holder in Biochemistry, Pharmaceutical Sciences, or a relevant area, preferably with work experience in quality control or quality assurance. The ideal candidate should bring:

  • Sound knowledge of stability of DS/DP and cGMP
  • Experience handling change controls, deviations, and CAPAs
  • Knowledge of chromatographic and bioassay methods
  • The ability to communicate clearly in English – both in speech and writing
  • Demonstrated experience in driving continuous improvement and/or productivity programs
  • A team player with the ability and desire to work independently

We are looking for someone who thrives in a challenging and dynamic environment, enjoys a rapid pace of work, and brings a positive, can-do attitude and a good sense of humor.

Location

Copenhagen Site