QC Technical Expert
Quality Control Technical Expert (Cell Therapy)
Would you love to be a part of a multi national, multi lingual team, delivering first class service to our many and expanding customers? Are you interested in working in world class scientific services? Are you looking for a new role that gives you something new to do every day?
This may be just the job for you...
Here at Lonza we have an exciting opening for a Quality Control Technical Expert (Cell Therapy) to join us on site in Geleen on a full time, permanent basis.
The Quality Control Expert implements and executes activities in the Quality Control department in the broadest sense while ensuring compliance with all existing GMP and safety standards. Acting as a contact person in complex issue handling and complex activity performance which requires knowledge and skills in the applicable expertise branch.
The position needs to thoroughly understand the activities linked to the applicable expertise, risk analysis, method implementation and other QC related issues in his/her branch
The technical Expert Cell Therapy will generate, review and approve QC documents and acts as expert for QC during internal and external audits and inspections.
Delivery of services in this role will include, but not be limited to:
- Good knowledge and experience of Quality Control (QC) methods and instruments
- Good understanding of QC analysis e.g. Flow cytometry, Elisa, safety tests or PCR
- Participates in the initial assessment of new methods to be transferred to QC
- System owner for method specific devices (initiation or review of URS, PQ and define maintenance requirements)
- The technical expert is expected to provide input for problem-solving of issues within his/ hers branch
- Interface with QC employees and contract labs as necessary to identify possible improvements and assess implementation with Supervisor QC
- To advise on and ensure generation, review and approval of QC documents in coordination with other departments and in accordance with cGMP
- Provide input in risk analysis for assessments where QC Cell Therapy input is required
- Suggesting and implementing process, planning and training improvements
You should have the following experience/knowledge:
- BSc/MSc in chemistry/biotechnology
- Proven experience with Quality Control and basic microbiological techniques (gram stain, sterility), endotoxin testing and flow cytometry/PCR
- Experience with GMP
- Strong planning, prioritization, and scheduling skills
- Strong ability to interpret data and troubleshoot testing in area of expertise.
- Excellent ability to problem solve. Changes work within their group quickly in unexpected situations.
- Outstanding ability to collaborate with other departments
If you’re a proactive, enthusiastic and organised person who’d like to hear more about this fantastic role, get in touch.