Quality Control Technician

Performance of environmental monitoring. Level 3 gowning qualification is required. There will be events where many hours within the cleanroom at level 3 gowning is required. Work hours may vary dependent on the demands of monitoring. Assist with the maintenance of laboratory/ media supplies and equipment. Supports investigations for environmental excursions; assist and revise standard operational procedures, trend reports, deviations, and corrective actions. Performs other duties as assigned. Performs water sampling and gas testing. Execute aseptic process validations, EM performance qualifications, and gowning qualifications. Inspect aseptic process qualification units. Performs Quality Control (QC) biological/cell based testing of Cell Therapy release and stability samples during 3rd shift. Typical test methods performed include flow cytometry based assays, but analyst may also perform proliferation, ELISA, cell counts (manual and automated), and immunofluorescence microscopy/spectroscopy assays. Actively participates in support of Cell Therapy technology transfer activities and validation of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols. Performs general lab and equipment maintenance duties. Performs other duties as assigned Skills Quality control, Laboratory, Chemistry, Gmp, Biology, microbiology Top Skills Details Quality control,Laboratory Additional Skills & Qualifications Bachelor's Degree in Scientific Discipline required Experience Level Intermediate Level