QC Analyst I

Duration: 8+ Months (40hrs/weeks)

Industry: pharmaceutical, biotechnology

OT may be required (may need to stay late if needed)

First 3-4 weeks will be M-F due to training

Bachelors degree is required in Scientific discipline.

0-4 years of experience.

Fresh grad is acceptable, ideally if they have had an internship or work in a research laboratory experience.

Performs Quality Control assays for product release of cell therapy products, Raw Material Release 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 Immunofluoresence, Sample Handling and Flow Cytometry.

• Performs Quality Control (QC) biological/cell based testing of Cell Therapy release and stability samples. Typical test methods performed include flow cytometry based assays, but analyst may also perform proliferation, ELISA, cell counts (manual and automated), and immunoflourescence 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.

• Completes 6S training and utilizes learning to help identify potential failure modes and implement visual management tools to error proof the lab

• Coordinates outsource testing and shipments for QC CT Group

• Performs other duties as assigned

Shift: 1st Shift, Wednesday-Saturday 8am-6pm