Quality Assurance Specialist

2 weken geleden

Groningen, Groningen, Nederland Thermo Fisher Scientific Voltijd

We are seeking a highly skilled and detail-oriented QC Technician to join our team at Thermo Fisher Scientific. As a key member of our analytical team, you will be responsible for ensuring the quality and integrity of our products.

This role requires a strong background in analytical methods and processes, with a focus on cGMP and EH&S guidelines and quality systems. You will work closely with our team to deliver reliable results and reports, and communicate effectively to ensure seamless collaboration.

Key Responsibilities:

  • Sampling and testing of samples for monitoring programs, general QC-activities like clerical- and administrative tasks, generic tests for cGMP projects, development, validation or stability programs
  • Assist in the improvement of Quality Control procedures, quality and quantity of output
  • Execution of generic tests for monitoring activities, raw material testing, GMP- and PD projects in the (bio)chemical laboratory and the microbiological laboratory and execution of general QC activities
  • Train (new) colleagues in the relevant QC procedures and use of specific equipment
  • Support in validation, development and stability testing (generic tests);
  • Write documentation for the work carried out for: generic analysis (analytical methods and equipment (manuals), data logging (analytical protocols and logbooks) raw material testing (specification sheets and article information sheet), generic validations studies (PQ)
  • Responsible as subject matter expert of assigned assays, and assures correct execution of testing according to procedures
  • Responsible for the proper functioning of specific equipment, as equipment owner expert user and/or trouble shooter, as agreed upon with the line manager. Execution of limited calibration and maintenance of equipment. Assure Equipment file is up to date with procedures, manuals and logbooks.

Requirements:

  • (K)MLO - laboratory education
  • Verbal and written English at MLO level is required
  • Specific knowledge of biopharmaceutical analytical fields like biochemical, microbiological and physical/chemical methods and applications is desired
  • Excellent knowledge and working in cGMP environment is desired

Experience in analytical techniques in the bio(pharmaceutical) fields is desired.

We offer a competitive salary of $65,000 - $80,000 per year, depending on experience, plus benefits including 8% holiday allowance, 21% shift allowance, 5% flex benefit allowance and 3% annual incentive bonus. We also offer a shift working hours arrangement, excellent career progression opportunities within a growing global employer, training and courses available via Thermo Fisher University to develop yourself, collaborative work in an international environment, strong Team Spirit and many company and team activities.

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