QC Analyst II
QC Analyst II
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Job Description
Overview:
TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with worldclass manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients bioscience biopharmaceuticals custom manufacturing and cell and gene therapy the company provides comprehensive services across the pharmaceutical biotech and life sciences sectors. It supports every stage of drug development from early research to commercial production and offers solutions in biologics small molecules and specialty ingredients. Committed to quality and innovation the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes with a global presence that ensures access to scalable flexible and compliant technical expertise.
Responsibilities
- 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 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.
- Performs other duties as assigned
Required skills & Qualifications
- Bachelors degree in a related stream is mandatory
- Prior hands on experience with Immunofluorescence Sample Handling and Flow Cytometry.
- Prior experience in performing flow cytometry based assays ELISA cell counts (manual and automated) and immunofluorescence microscopy/spectroscopy assays.
Employment Type
Full Time
