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Job Description

General Summary:

The Quality Control Specialist is responsible for supporting with various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. This role will also assist with conducting and validating various biological and chemical quality control (QC) assays.

Key responsibilities:

• Performs Quality Control (QC) testing of Cell Therapy in-process, release and stability samples. Typical test methods performed include flow cytometry, qPCR (MycoTOOL), ELISA, cell counts, sterility (BACT), Gram stain and endotoxin (LAL) testing

• Assists in tracking and trending of QC data

• Performs technical reviews of raw data

• Records test results and maintains raw data and accurate laboratory records

• Performs general lab and equipment maintenance duties.

• Improving the laboratory—including managing reagents, materials, improving lab flows, et cetera—with minimal managerial support

• Performs other duties as assigned

Knowledge and Skills:

• Ability to performs tasks with strict adherence to cGMP and cGDP principles and high attention to detail

• Understanding of basic laboratory equipment and practices

• Proficient in the use of spreadsheets and word processing software

• Ability to problem solve by selecting appropriate alternative from defined options

• Demonstrates reliability, positive attitude and team work

• Shows initiative; acts independently with management approval

• Role involves rotating weekend, holiday, and evening work

Education and Experience:

• Bachelors Degree in Sciences or equivalent experience

• 1+ years of relevant experience

Company Information