Kwaliteit en milieuspecialist
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5. qc analyst
qc analyst.
6. zwijnaarde, oost-vlaanderen
7. 1 dag geleden gepubliceerd
8. sluit 18 oktober 2023
solliciteer
jobdetails
samenvatting
9. zwijnaarde, oost-vlaanderen
10. vast
11. 40 uren per week
12. functiegroeptechniek
13. referentieDUORS-1494034
jobdetails The QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing
QC testing related to the manufacturing of cell therapy products for clinical trials and commercial
operations in a controlled GMP environment.
Major Responsibilities:
...- 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
toon meer The QC Analyst, CAR-T Manufacturing is an exempt level position with responsibilities for performing
QC testing related to the manufacturing of cell therapy products for clinical trials and commercial
operations in a controlled GMP environment.
Major Responsibilities:
- 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
toon meer
14. ervaring
3-5 jaar
15. taken
Werken op afdeling sterilisatieKlinische scheikundeLaboratoriumapparatuur
16. jouw aanbod
- Indicatie eigen vervoermiddel: Nee
- Ploegenstelsel: Vol continue
- Voorkeuren: Perm (type job), Normaal (werknemerstype), (salaris), (dienstvorm)
17. opleiding
Professionele bachelor
18. ons aanbod
bedrijfsprofiel
This company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide....toon mindertoon meerThis company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.