Scientist, Quality Control Specialist
1 month ago
The Role
You will be part of the QC Stability Team, a key component of Quality Control at AGC Biologics. Your primary responsibility will be to handle stability studies of Drug Substance, Drug Product, Placebo, and Reference Material.
Your day-to-day activities will involve collaborating with various stakeholders, including customers, project managers, management, your department, and QA. You will work closely with your team members to identify and manage analytical stability packages for customer projects.
Key Responsibilities
- Develop and review CR, Deviations, and CAPA documents
- Write and review customer-specific stability protocols and reports
- Engage with customers on stability-related topics
- Oversee testing at external laboratories
- Ensure compliance with cGMP guidelines (EU, FDA)
The Department
You will be part of the QC Support team in the QC laboratory, working alongside a team of 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 related field, with preferably some experience in quality control or quality assurance. The ideal candidate should possess:
- Sound knowledge of stability of DS/DP and cGMP
- Experience handling change controls, deviations, and CAPAs
- Knowledge of chromatographic and bioassay methods
- Excellent communication skills in English
- Demonstrated experience in driving continuous improvement and/or productivity programs
- A team player with the ability to work independently
We value a positive, can-do attitude and a good sense of humor. If you thrive in a challenging and dynamic environment and enjoy a rapid pace of work, we encourage you to apply.
Location
Copenhagen Site
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