Sr. QC Technician
Thermo Fisher Scientific
Naarden, Noord Holland, NLD
4 dagen geleden

Thermo Fisher Scientific is currently recruiting of for a Quality Control Technician at BAC BV in Naarden, the Netherlands.

BAC, part of TFS, is a biotech company that develops and manufactures products for the purification of pharmaceutical products, for small scale purification and for analytical applications.

A large range of CaptureSelect™ products is sold worldwide to universities, research institutes and the (bio)pharmaceutical industry.

Baker’s yeast S. cerevisiae is used for the production of these proteins. The generation of the production cell strains and the manufacture of the ligand is executed according to an own developed and patented system.

The R&D site is located in Leiden, the manufacturing site is located in Naarden .

Description of the Quality Control unit :

  • The Quality Control (QC) unit is part of the Quality Assurance & Regulatory Affairs department. The QC unit is responsible for the development and qualification of analytical methods, analysis of intermediate and final product samples and samples from process development
  • In addition, the QC unit is responsible for the management of outsourced testing and the execution of stability studies
  • Within QC there is a vacancy for a QC technician
  • The QC technician reports to the Director of QA & RA.
  • Key Responsibilities :

  • Execution of analyses (HPLC / UPLC (SEC, Affinity, RP), spectrophotometry, microbiology, electrophoresis, pH, conductivity, ELISA) on samples from production
  • Development of analytical methods (including generation of work plans, execution of the work plan and generation of a development report)
  • Validation of analytical methods according to a protocol including the generation of a validation report
  • Correct documentation of test results according to documented instructions
  • Generation and revision of Standard Operating Procedures (SOP’s)
  • Perform and report stability studies
  • Calibration of analytical equipment
  • Review of analytical data
  • Participate in projects, support of QA.
  • Skills Required :

  • You operate at BSc. Level (analytical, biochemistry or comparable) and have a proven track record working in a laboratory
  • You know how to operate with quality standards as cGLP, GMP or ISO9001
  • You can work in a team as well as independently
  • You are prepared to work a few days per year in a late shift ( : 00 20 : 30 hrs.)
  • You master the English language (both orally and in writing).
  • Preferred Qualifications (nice to have) :

  • Experience with HPLC / UPLC and / or protein analyses
  • You have at least 3 years of relevant work experience
  • You have experience with development and validation of analytical methods
  • Dutch language is preferred but not essential
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