Quality Control Analyst - Malvern - Insight Global

    Insight Global
    Insight Global Malvern

    3 days ago

    $48,000 - $82,000 (USD) per year * Pharmaceutical / Bio-tech
    Description

    JOB DESCRIPTION:

    The QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of other Analysts within a functional Clinical Release and Stability Laboratory and report to the Senior QC Supervisor. Key Responsibilities:

    -Conduct analytical biological testing of clinical and commercial drug product/drug substance samples

    -Perform peer reviews and approvals of laboratory data

    -Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data

    -Support of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/management

    -Perform Instrument Calibration and Preventative Maintenance

    -Update CRS-owned documents using the Document Management System (DMS)

    -Order/receive supplies and manage inventory

    -Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities

    -Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight

    -Act as a peer subject matter expert in assessing talent by participating in panel interviews for job

    -Complete invalid assay and general laboratory investigation records

    -Complete corrective and preventative actions (CAPA) as assigned

    -Assist in the execution of internal audits

    REQUIRED SKILLS AND EXPERIENCE:

    -Minimum one year of relevant GMP QC work experience in Pharmaceutical lab

    -Bachelor degree in Biology or Chemistry

    -Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)

    -Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories, specifically with Flow Cytometry

    -Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols

    -Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)

    NICE TO HAVE SKILLS AND EXPERIENCE:

    -CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience

    -Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC

    -Ability to complete equipment and software qualification protocols

    -Experience developing and setting long-term objectives

    -Experience working in Biosafety Level lab (BSL 2, BSL2+) or aseptic facility

    -Knowledge of EU/FDA guidance

    * This salary range is an estimation made by beBee
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