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    Quality Assurance Compliance Specialist - Bedford, United States - Actalent

    Actalent
    Default job background
    Full time Pharmaceutical / Bio-tech
    Description

    Great opportunity to get your foot in the door with one of the top Biotech Companies in the Billerica, MA area

    **Must have experience with Product Quality Complaints and Annual Product Quality Reviews**

    Top Skills' Details:

    Quality Assurance

    Product Compliance

    APQR (Annual Product Quality Reviews)

    Root Cause Analysis

    Quality Management System (Trackwise)

    Description:

    Help with documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations

    technical investigations relating to Product Quality Complaints

    Run quality investigations and risk assessments

    Help run Annual Product Quality Reviews

    Manage QMS (Trackwise)

    Write and review SOPs and test methods

    Additional Skills & Qualifications:

    BS in chemistry or related scientific field

    6-8 years experience in pharmaceutical manufacturing

    Understand GMP/GLP

    Understand QMS and Trackwise

    Exposure to SAP, EDMS, LMS, Master Control

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

    Diversity, Equity & Inclusion

    At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

    • Hiring diverse talent
    • Maintaining an inclusive environment through persistent self-reflection
    • Building a culture of care, engagement, and recognition with clear outcomes
    • Ensuring growth opportunities for our people

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.

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