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QC Analyst, Microbiology

Company: Actalent
Location: Newark
Posted on: January 15, 2022

Job Description:

Hiring a QC Analyst to join a Bay Area Biotech company focused on t-cell therapy.This position provides Quality Control microbiological testing for clinical and commercial manufactured product, responsible for product testing, utility testing and environmental monitoring. -Responsibilities include, but are not limited to: - Perform environmental monitoring of utilities and facilities - Perform LAL and Sterility testing of final drug product per compendial methods - Perform media growth promotion, gram staining, and microbial ID test methods of isolates per compendial methods - Perform TOC testing of water samples - Perform bioburden and LAL testing of incoming raw materials - Work with internal and external resources to maintain lab in an optimal state - Monitor and trend data - Assemble reports on findings from environmental monitoring of facility, frequently update management on environmental trends and implement corrective action plans when necessary - Revise and review SOPs - Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures. - Monitor the GMP systems currently in place to ensure compliance with documented policies - Gather metric information for use in continuous improvement of areas of responsibility -Additional Skills & Qualifications:

  • Bachelor 's degree in Microbiology preferred OR direct experience in QC Microbiology lab
  • Experience in the application of microbiological techniques such as air monitoring gases, water testing, surface monitoring, genus and species identification of isolates
  • Experience with aseptic technique and clean room operations
  • Bioburden, Endotoxin, LAL testing experience
  • Strong knowledge of GMP, SOPs and quality control processes

    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.

Keywords: Actalent, Newark , QC Analyst, Microbiology, Professions , Newark, California

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