The QC Microbioogist will support quality control testing operations at a client's 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/or 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