Neuroplast BV, a Maastricht/Geleen based biotech company is looking for a
QUALITY CONTROL ASSOCIATE (M/F)
The Quality Control Associate will be responsible for planning and execution of daily quality control activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. EMA, ICH) and applicable GMP standards in the area of responsibility.
You will be a critical part of a dynamic internationally active biotech-company in the field of regenerative medicine.
- Plan, execute, analyze and document quality control activities (Flow cytometry, qPCR, hemocytometry) of a cell based human medicinal product (ATMP) under GMP Sample and perform testing of raw materials, process intermediates and finished products according to specifications and applicable guidelines (EP)
- Maintain and document reference standards and control materials
- Perform, document and analyze environmental monitoring
- Control of starting material and product transport parameters and conditions
- Participate in multiple projects aiming at improving existing or implementing new quality control processes and analytical methods within a GMP-regulated field.
- Ensure QC equipment is maintained, calibrated, qualified and routinely checked.
- Write and review QC-related documentation (SOP's, batch records, validation plans and reports, OOS, non-conformances).
- Analyze and prepare data for trending (reference standards, product results) and maintain the QC-related databases.
- Support internal and external audits.
Position requirements, and competences:
- BSc or MSc in biology, biotechnology, biomedical sciences, biomedical engineering and 2-year experience in research laboratories or industry.
- Highly proficient in flow cytometry (demonstrable track record).
- Knowledge and proficiency in qPCR and sterility testing.
- Knowledge of GMP, and preferable experienced with cellular products.
- Fluent in English (verbal and written).
- Accurate, proactive, self-organized, attention to detail, team player.
- Analytical and problem-solving skills.
- Flexible, willing to work outside of general office hours (preplanned).