Jobs

    Senior Quality Assurance Specialist - Massachusetts, United States - Randstad Life Sciences US

    Randstad Life Sciences US
    Randstad Life Sciences US Massachusetts, United States

    18 hours ago

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    Description

    Quality Systems and Distribution Specialist (Senior)

    Duration: 6 Months, likely to be extended

    Rate: Up to $50 per hour

    Working Hours: Wednesday to Saturday, 10-hour shifts

    Job Responsibilities

    • Confirm release process for CMO batches, verifying Veeva documentation and SAP steps
    • Review batch records when necessary
    • Support administration for document archiving in Veeva eQMS
    • Ensure compliance with training requirements
    • Address CMO documentation issues in coordination with CS leads and CMO leads
    • Provide support for Compliance, operational excellence projects, and quality project management based on skills and experience

    Education & Qualifications

    • Senior specialist level (5+ years of experience)
    • Strong communication skills
    • Knowledge of regulatory requirements
    • Experience with Veeva systems or similar quality document management
    • Background in performing batch record review and disposition
    • Understanding of Drug Product GMP Manufacturing
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