Qc Ipl Analyst

**QC IPL Analyst**:

- Location:
Ghent, Belgium
- Contact:
Dardo Helpers
- Job type:
Temp to Perm
- Contact phone:
+32 15 44 58 52
- Industry:
Biotechnology
- 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 necessar

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.
- Excellent written and oral communication skill are required