Job Description

Description:

We are seeking a Quality Control (QC) Analyst to join the team at the company\'s satellite location., This facility produces a critical raw material used in the company\'s TIL process. The critical raw material is processed from leukapheresis units and frozen.

The QC Analyst will support quality control microbiology testing operations. The quality control microbiology testing programs include in-process and final drug product microbial testing such as bioburden, endotoxin, gram stain, environmental monitoring, compressed gas monitoring, and/or sterility techniques.

Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.

Perform environmental monitoring of the cleanroom areas as scheduled.

Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.

Perform all activities with respect to cGMP compliance.

Perform microbial identification, endotoxin, bioburden, gram stain and sterility testing

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

Additional Skills & Qualifications:

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

Minimum three (3) years of GMP experience in the pharmaceutical industry within a Quality Control role; experience with cell therapy products is a plus.

Experience performing environmental monitoring

Experience with EM testing such as bioburden, endotoxin, microbial identification, gram stain and sterility testing

Aseptic Gowning experience

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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