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Quality Control Associate - Netherlands  

PharmaCell (company)


Posted on : 10 April 2017

Project Description

The Position
  • 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