- You will work under the direction of the Team Leader QC in a team of young, driven professionals in a GMP environment on projects related to cell therapy and regenerative medicine.
- The Quality Control Associate works with autologous and allogeneic cell products in accordance to GMP conditions.
- Together with colleagues in Manufacturing and Quality Assurance the Quality Control Associate will be instrumental in the successful release of patient-specific medicines.
- In this position individuals can make an important contribution to advancing this exciting new area of drug development for a number of international clients.
- You have affinity with GMP guidelines and you like to work in a quality-oriented environment.
- Experience in writing, performing and reporting bio-analytical procedures in a QC environment (ELISA, FACS, cell counting, viability, sterility testing etc.) is a must.
- Additional experience in Microbiology is of added value.
- You are a people-oriented team player, pro-active thinker, pragmatic, accurate, precise, constructively critical and service/quality-driven.
- A good sense of humour and the willingness to work flexible hours when required is important.
- Responsible for sampling, handling and testing of (micro)biological materials
- Responsible for QC testing and documentation compliant to cGMP. Tests involve cell biological and microbiological techniques.
- Responsible for reporting to Team leader QC or designee
- Responsible for testing and release of incoming materials
- Ensure proper operations of laboratory equipment
- Involved in the revision of cGMP documents like Standard Operating Procedures, test forms, part specifications
- Responsible for the initiation of Out of Specifications, Non-Conformances, Planned Deviations and Corrective And Preventive Actions
- Responsible for cross-departmental cooperation to ensure timely processing and reporting of results
- HLO degree in Molecular Biology, Biotechnology, Medical Biology or equivalent with focus on cell biology and/ or human cell culturing techniques (stem cells, primary cells and/or tissue culture)
- 2-5 year experience in an industrial QC laboratory working on cell biological and cell culturing techniques (Environmental Monitoring, reading of microbiological culture plates, isolation of micro-organisms, safety testing, ELISA and flow cytometry training is essential)
- Expertise in applying international GMP regulations and guidelines to analytical methods in a QC environment
- Knowledge of microbiology
- Experience with cGMP is highly preferred
- Good proficiency in English
- Good knowledge of standard MS-Office products