The Quality Control Analyst will support quality control testing operations at a clients Cell Therapy Center (iCTC). The quality control testing programs include in-process and final drug product microbial testing such as bioburden, endotoxin, gram stain, environmental monitoring, and sterility techniques.
* Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility
* Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times
* Perform all activities with respect to cGMP compliance
* Support thorough cGMP investigations for out-of-specification test results
* Support technical problem solving
* Support product stability programs including execution of stability testing, stability data analysis, and final reporting of stability data
* Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results