YOUNG GRADUATES - BACHELOR IN BIOCHEMISTRY, CHEMISTRY OR BIOLOGY | QC Analyst

Our client, a biotech company, based in Zwijnaarde, is a global biotechnology company bringing the innovative cell therapy to Ghent. With this, the 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.

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 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

- Education:

You have you have a Bachelor's degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical 

industry.

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 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.