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Assistant Scientist Sample Management team and Raw-materials

2019-03-05 CLS Services | Leiden | HBO | Fulltime | Sluit 2019-05-04

Based on the needs within the QCD Labs organisation, this function is to operate within two of the QCD labs groups; the Raw-Materials Team and Materials and Sample Management Team on a roughly 80/20 basis (thus focus on Raw Materials). We are looking for a motivated QC technician who enjoys ...

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Vaccines & Prevention, we are searching for an Assistant Scientist Sample Management team and Raw-materials.

Company profile
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.

Department
The QCD labs group is part of the Analytical Development Department of the Pharmaceutical and Analytical Development sector. Overall, the QCD Labs unit consist of 6 sub-teams (Raw-Materials, Sample Management, Cell Culture, Microbiology, Co-ordination and Technicians) and is responsible for release and stability testing as well as the corresponding reporting of Janssen’s virus and antibody products for use in clinical trials and the analytical support of the pilot plant activities.

The QCD Labs group focuses on supporting production and laboratory activities with:

  • Inspection, release and change management of incoming production raw materials and laboratory chemicals (Raw-Materials Team);
  • Sample and Material receipt, handling, storage and forwarding (Sample Management Team);
  • Cell Culture services where cells are maintained used for assays and production cell line quality is supported (Cell Culture Team);
  • Microbiology group mainly responsible for maintaining controlled state of production clean room and production utilities by environmental and utility monitoring programs (Microbiology Team);
  • Co-ordination of Release and Stability testing and Outsourcing Co-ordination (Co-ordination Team);
  • All internal release and stability testing (Technicians Team).


Job description
Based on the needs within the QCD Labs organisation, this function is to operate within two of the QCD labs groups; the Raw-Materials Team and Materials and Sample Management Team on a roughly 80/20 basis (thus focus on Raw Materials).
We are looking for a motivated QC technician who enjoys working in a multidisciplinary environment.
Within the Raw-Materials Team incoming purchased raw materials used within cGMP activities are inspected and tested to support the release of the material for use.
Main tasks for the team are:
  • Perform physical and documentation inspections and labelling on incoming raw materials;
  • Taking samples of raw materials and make sure these are distributed to various (external) testing laboratories;
  • Perform various tests on incoming raw materials as identification, pH, conductivity and osmolality;
  • Receipt and record inspection and test results;
  • Review of work performed by colleagues;
  • Supplier changes;
  • Setting up specification documentation for raw materials;
  • Having close contact with warehouse and users.

Within the Materials and Sample Management Team, materials and samples used for Release and Stability Testing are received, stored and forwarded to external parties according to GMP.
Main tasks of the team are:
  • Sample receipt, storage and forwarding according to cGMP;
  • Preparation of shipping documentation;
  • Maintain up to date lab planning;
  • Maintain up to date inventory of materials and samples;
  • Process and review incoming Certificates in the appropriate systems (e.g. LIMS);
  • Support Co-ordination Team with LIMS configuration.

Documentation and Quality (cGMP) and efficiency improvements are important factors within Analytical Development. It may be an excellent opportunity for Technicians who want to pursue their career in a job more outside the labs.

Who we're looking for
We are ideally looking for candidates with a relevant BSc. and affinity with medical products, experience with quality and laboratory systems such as cGMP, SAP and LIMS are strong advantages. You have 3 years of experience working in the pharmaceutical industry and working according to cGMP. Documentation plays a major role and experience is considered as a must.
Routine is about 30% (work variable, materials continuously different). You need strong communication skills both in English and Dutch due to heavy interaction with other departments.

Additional vacancy information
Reference: A1900030
Contract: Temporary contract with CLS Services
Education: HBO/BSc.
Terms: Project for 1 year, longer-term anticipated.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555



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