What are the responsibilities and job description for the Quality Control Analyst position at Entegee?
Performs Quality Control assays for product release of cell therapy products and Stability Studies. Maintain data and follow cGMP regulations including writing deviations and other Quality documentation. Skill set includes (but is not limited to) working knowledge of Immunofluorescence, Sample Handling and Flow Cytometry.
• 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
