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QC Analyst III

Meet
Norton, MA Full Time
POSTED ON 2/26/2025
AVAILABLE BEFORE 5/23/2025
  • Friday-Monday
  • 10-hour shifts
  • Job Summary :

    The Quality Control Analyst III plays a key role in ensuring high-quality standards and compliance throughout the product lifecycle. This position involves performing routine and non-routine testing, supporting data trending and investigations, and contributing to method transfers, qualifications, and implementations to enhance QC operations.

    Responsibilities :

    • Perform routine and non-routine analytical / microbiological assays for raw materials, in-process samples, product release, and stability studies.
    • Support laboratory operations (Analytical, Microbiology, Raw Materials) for continuous coverage.
    • Maintain training records, adhere to testing schedules, and ensure timely completion of QC tasks.
    • Assist with equipment maintenance, reagent / sample preparation, and ensure seamless lab operations.
    • Review data and qualify as a data reviewer to ensure timely data availability.
    • Contribute to the revision of controlled documents (SOPs, work instructions) for compliance and continuous improvement.
    • Adhere to GMP, GLP, and ICH guidelines to maintain quality standards.
    • Support cross-functional teams and collaborate on QC process enhancements and regulatory compliance efforts.
    • Qualifications :

    • B.S. in chemistry, biology, biochemistry, or a related field.
    • Minimum of 4 years in a GMP Quality Control role, with experience in method transfer and analytical method implementation.
    • Proficient in data analysis and interpretation.
    • Strong problem-solving and investigation skills, including CAPA implementation.
    • Experience with LabWare LIMS, Excel, Word, and PowerPoint.

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