Vacancy expired!
We are seeking a highly motivated Quality Control Specialist to work with cell therapy projects. In this role, the incumbent will support raw material, in-process, release and stability testing for vaccines and cell-based assays. The successful candidate's primary responsible is to support new drug product development, method transfer/method validation of immunology/ cell-based assay according to GMP SOP.
Job responsibilities:- Process donor screening testing, release, and stability testing on cellular products/specimens according to standard operating procedure (SOP) using aseptic technique.
- Perform and analyze results of quality control testing of components, including automated cell counts and flow cytometry.
- Prepare reagents and materials for test methods.
- Participate in method validation and method transfer activities.
- Complete assigned deviations, CAPAs, Change Controls and laboratory investigations in a timely and efficient manner.
- Flexibility to learn and support the QC Microbiology area on techniques such as environmental/facility monitoring, sterility, BacT Alert, and endotoxin.
- Perform data analysis using flow cytometer in accordance with standard operation procedures
- Aseptic technique
- Cell count/viability
- Cell based assays
- Flow cytometry
- qPCR
- Bachelor's Degree and 4+ years of regulated industry experience, or equivalent combination of education and experience.
- Experience in Quality Control function in a GMP manufacturing operation.
- Expertise in GMP compliance and FDA/EMA regulations.
- Background in Cell Therapy Manufacturing is preferred.
Vacancy expired!