Leiden, Gemeente Leiden, South Holland
QC Technical Specialist Bioassays
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies and vaccines to protect people worldwide from immunological diseases
As a Technical Specialist you will join the Bioassays team within the QC department, responsible for the testing of end products. You will handle quality and compliance related issues (high-level deviations, CAPAs, assessments) to maintain cGMP compliance.
1. Deviation Management
- Investigate local/global Non-Conformances, provide product impact assessments and defining CAPAs.
- Monitor timely closure of medium/high-level investigations and associated CAPA’s.
- Supporting and advising other lead investigators from external and internal QC departments.
2. Lab Execution
- Coordinate activities related to NPI introductions.
- Ensuring that assays can technically be executed in an efficient and cGMP compliant manner.
- Crafting URSs for equipment
- Gathering and analysis of assay performance data
- Lead and drive continuous improvement
- BSc or MSc in Life Sciences
- Min. 2 years of experience with Bioassays (ELISA, cell cultures, PCR)
- Min. 2 years of experience in a GMP lab
- Excellent communications skills in English
For more information please contact Carla Garcia at firstname.lastname@example.org or +31 (0) 20 658 98 01.