For our site in Maastricht we are looking for a:
Quality Control Associate (full time)
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