Job Description

Description:

The Quality Control Analyst will support quality control testing. The Quality Control testing programs include, but are not limited to, in-process, final drug product, and stability testing with a focus on cell therapy products. We are looking for a person that has hands-on laboratory experience handling primary and/or continuous cell lines and the execution of cell-based potency and identification assays using various immunoassay (ELISA, etc.) and flow cytometry platforms. This position will support the ramp up of QC and other activities

• Perform daily GMP quality control laboratory testing activities at the cell manufacturing facility

- Testing will include Flow Cytometry, ELISA, PCR and cell culture (counting, and cell viability)

• Perform data analysis and final result reporting to support product lot release with adherence to turnaround times

• Perform all activities with respect to GMP compliance

• Support thorough GMP investigations for out of specification test results

• Support technical problem solving for issues pertaining to GMP quality control

• Support product stability programs including execution of stability testing, stability data analysis, and final reporting of stability data

• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results

Skills:

Molecular biology, Laboratory, Qc, GMP, Assay, ELISA, flow cytometry, Cell Culture, Cell count viability, Cell Count, sterility

Additional Skills & Qualifications:

• Bachelor\'s degree in a relevant discipline (biological sciences or equivalent)

• Minimum three (1) years of experience in the Bio-pharmaceutical industry within a Quality Control role; experience with cell therapy products is a plus

- GMP experience a MUST

- Experience Successfully interface with multi-disciplined teams

• Extremely detail-oriented with flow cytometry, ELISA or PCR a MUST (one of these at a minimum) - mammalian cell culture, cell count and cell viability also a nice to have

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We\'re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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