Scientific Quality Assurance Specialist

2 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

AGC Biologics seeks a skilled QC Scientist to join our Quality Control laboratory as part of the QC Stability Team. This temporary one-year position offers a unique opportunity to contribute to the stability studies of Drug Substance, Drug Product, Placebo, and Reference Material.

The successful candidate will be responsible for ongoing collaborations with stakeholders such as customers, project managers, management, their own department, and QA. Alongside team members, they will work on stability aspects of customer projects, including identifying and managing analytical stability packages needed for the projects.

Key responsibilities include:

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

Quality Control Support Department

The selected candidate will join a team of dedicated scientists and technicians in the QC laboratory. The QC Support department consists of three sections: QC Raw materials, QC Samples & Service, and QC Stability.

Ideal Candidate Profile

To be successful in this role, the ideal candidate should hold an MSc in Biochemistry, Pharmaceutical Sciences, or a related field and preferably have experience within quality control or quality assurance. Additionally, we expect them to bring some of the following experience and characteristics:

  • Sound knowledge of stability of DS/DP and cGMP
  • Experience handling change controls, deviations, and CAPAs
  • Knowledgeable 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 combined with the ability and desire to work independently

Furthermore, the candidate should thrive in a challenging and dynamic environment and enjoy a rapid pace of work. They should bring a positive, can-do attitude and a good sense of humor.

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