Quality Assurance Compliance Specialist - Bethlehem - Masis Professional Group

    Masis Professional Group
    Masis Professional Group Bethlehem

    14 hours ago

    Pharmaceutical / Bio-tech
    Description

    Quality Assurance Compliance Specialist | 2nd Shift

    3pm to 11:30pm

    Bethlehem, PA

    $65,000–$75,000 base + annual bonus

    Direct Hire | Stellar benefits | Career growth

    No C2C or C2H

    A growing pharmaceutical manufacturing site is expanding its QA team and looking for a Quality Assurance Compliance Specialist on 2nd shift who enjoys being hands-on, detail-driven, and truly involved in GMP operations. This team is known for being collaborative, supportive, and tight-knit.

    What You'll Be Doing:

    • Review manufacturing & packaging batch records (paper + electronic) for product release
    • Review lab data and generate Certificates of Analysis (C of A)
    • Release product in SAP and generate quality reports
    • Support documentation control, archiving, and QA record management
    • Review calibration records and support quality systems compliance
    • Assist with deviations, investigations, APRs, CRNs, BOMs, and MBR updates
    • Support FDA and regulatory audits
    • Perform packaging line inspections as needed
    • Train new QA team members and provide QA cross-coverage
    • Support new product launches and special QA projects

    What We're Looking For:

    • Bachelor's degree in a science or technical field (Chemistry preferred) or equivalent experience
    • 5+ years experience in a regulated industry (pharma or medical device)
    • Strong working knowledge of FDA regulations, GMPs, GDPs, and GLPs
    • Experience in manufacturing and/or packaging environments
    • Familiarity with quality systems and document control
    • Proficiency in Microsoft Office; SAP, TrackWise, EDMS a plus
    • Strong communication, problem-solving, and critical-thinking skills

    Why This Role?

    • Direct hire stability
    • Excellent benefits package
    • Annual bonus potential
    • High visibility within QA and operations
    • Room to grow as the site continues to expand

    Interested or know someone great? Message me for details or apply today.


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