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    Quality Assurance Specialist - Norwood, United States - Randstad Life Sciences US

    Randstad Life Sciences US
    Randstad Life Sciences US Norwood, United States

    2 weeks ago

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    Description

    6 Month Contract

    Norwood, MA

    PR: $35-50/hour

    Job Summary

    The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug products produced internally at this client. He/she will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. The successful candidate will have experience in quality oversight or manufacturing experience in early stage clinical products. They will be able to interact fluidly with peers and supervisors in Manufacturing, and cross-functionally with Quality Control, Manufacturing, Logistical and Process Development Technology Transfer counterparts.

    Job Responsibilities

    • Conduct thorough review of Master Batch Records (MBR) and electronic Batch Records (eBR), collaborating closely with the manufacturing team to ensure timely finalization of documentation.
    • Perform quality inspections of logbooks that are pending review to ensure compliance and completeness.
    • Provide quality supervision during the implementation of corrective actions and preventive actions (CAPA) and verify the effectiveness of these actions to sustain production continuity or advance processes to subsequent phases.
    • Oversee the resolution of quality documentation, including deviations, change controls, CAPAs, Process Improvements (PI), and Engineering Changes (EC), prioritizing collaboration with interdisciplinary teams to expedite the completion of these records, addressing them in order of receipt or as per the backlog.
    • Review and certify scanned copies of GMP documents submitted for archive.
    • Additional duties as may be assigned as needed

    Education & Qualifications

    • 2-4 years of experience in a GMP Manufacturing environment
    • Bachelor's degree in a science related field
    • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.


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