Technics

Technics

QC Analyst

9052 ZWIJNAARDE
Vast contract
Bachelor
35 u/week
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Functieomschrijving

For our client in Zwijnaarde, we are looking for a QC Analyst. 

Your tasks and responsabilities include:

  • Responsible for the completion of QC testing related to the manufacturing of autologous CART products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
  • Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
  • Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
  • Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
  • Perform peer review/approval of laboratory data.
  • Utilize electronic systems (LIMS) for execution and documentation of testing.
  • Create, review and approve relevant QC documents, SOP’s and WI’s.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Other duties will be assigned, as necessary

Profiel

- Education:

You have you have a minimum of an A2 diploma and a maximum of a Bachelor's degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical  industry.

- Experience:

You have a minimum of 1-2 years relevant work experience in pharmaceutical environment is required.

You  have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. 

 

Capabilities, Knowledge, and skills:

  • Experience in a Quality Control setting is preferred.
  • Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
  • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
  • Knowledge of Good Tissue Practices is required.
  • Detailed knowledge of CAR-T QC test methods and related equipment is preferred
  • Excellent written and oral communication skill are required
  • Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
  • Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
  • Comfortable with speaking and interacting with inspectors.

Aanbod

  • You will join an exciting pharmaceutical company with opportunities for growth.
  • You will work within a strong and respectful diverse team where everyone is welcome.
  • Your Team is a diverse team who speaks Dutch or English
  • You will receive an attractive salary package including meal vouchers and eco vouchers.
  • Hospitalisation insurance, group insurance and bonus complete the salary package.
  • You will work in a 2-shift system (6 am - 4 pm / 2 pm - 00 am) in a regime in which you work 4 days, have 4 days off, etc. This gives you a nice balance between Work and Personal life
  • You will work in an environment where loyalty and team spirit 

Bedrijfsinfo

Our client, Legend Biotech, based in Zwijnaarde, is a global biotechnology company bringing the innovative CAR-T cell therapy to Ghent. With this, the Legend Biotech team makes a daily difference in the lives of many patients suffering from cancer and other life-threatening diseases. They are currently in a phase of strong growth and are looking for motivated and dedicated team members.

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Start People Gent GT
+32 (0)9 269 37 20
gent@startpeople.be
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