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    QA Associate - Toronto, Canada - Apex Systems

    Apex Systems
    Apex Systems Toronto, Canada

    1 week ago

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    Description

    QA Associate (Document Review)

    Apex Systems is a large staffing and consulting firm and we are looking for a QA Associates with experience with QA documentation review, exposure to GMP/GDP, and a background in life sciences for one of our biotech clients in Toronto.

    Client: Biotechnology company

    Contract/Perm & duration: 6-month contract (possibility of extension/conversion)

    Location: Toronto

    This position will be working 100% on-site as it is required for daily responsibilities

    Responsibilities:

    • Reviewing executed batch records and equivalent production documents, as well as assisting in closure of batch record review backlog
    • Supporting day-to-day operations such as room release and reviewing manufacturing and equipment changeover activities
    • Reviewing quality events, including deviations, lab investigations, CAPAs, and change controls
    • Supporting document reviews, including but not limited to SOPs, COAs, protocols, and reports
    • Working closely with both Manufacturing, Quality Control, and Facilities teams in any quality matter
    • Responsible for performing quarterly walkabouts, following up on the observations, and supporting 5S excellence projects
    • Supporting various process improvement projects, contributing to the overall success of the GMP operations at MaRS7 and PMCRT-15 (Toronto GMP Sites

    Key qualifications:

    • Undergrad or master's degree in biological sciences, analytical chemistry, chemical engineering, biomolecular engineering, microbiology, or similar
    • 1-2 years experience in GMP industry (junior level)- Any experience in biotechnology industry is preferred but not required
    • Strong knowledge on GMP and GDP
    • Strong critical thinking skills when working on new procedures or process improvements
    • Strong teamwork and communication skills
    • Strong written and verbal communication skills and efficient in communicating to inter-disciplinary and cross-functional team
    • Detail-oriented individual with a passion for quality and a strong desire to contribute to a dynamic team
    • Proactive and able to work in a fast-paced team environment while prioritizing tasks for multiple projects
    • Familiar with electronic document and quality management systems (preferred but not required)
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