Clinical Laboratory Scientist

AccuScan Sciences

  • Milpitas, California
  • 3 days ago
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    Skills

    • Assay Developmentunmatched
    • Assay Verificationunmatched
    • Assaysunmatched
    • Biochemistryunmatched
    • Clinical Laboratoryunmatched
    • Corrective Actionunmatched
    • DNAunmatched
    • Data Qualityunmatched
    • Documentation Standardsunmatched
    • Geneticsunmatched
    • High Throughputunmatched
    • Instrumentationunmatched
    • Laboratoryunmatched
    • Laboratory Operationsunmatched
    • Maintain Complianceunmatched
    • Molecular Analysisunmatched
    • Molecular Biologyunmatched
    • Next Generation Sequencing (NGS)unmatched
    • Process Improvementunmatched
    • Public Healthunmatched
    • Quality Controlunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Testingunmatched
    • Validation Testingunmatched

    Description

    Description

    AccuScan Sciences is seeking a California-licensed Clinical Genetic Molecular Biologist Scientist (CGMBS) to support and scale high-complexity molecular diagnostic testing within a CLIA-certified laboratory environment. This role is designed for an experienced molecular laboratory professional with demonstrated expertise in high-throughput next-generation sequencing (NGS), assay development, laboratory build-out, and regulated clinical operations.

    Key Responsibilities

    Clinical Operations & High-Complexity Testing

    ·       Perform and oversee high-complexity molecular testing including DNA extraction, sample preparation, and NGS workflows

    ·       Review and verify test results according to laboratory SOPs and regulatory requirements

    ·       Ensure compliance with CLIA, CAP, and California Department of Public Health regulations

    Laboratory Build & Optimization

    ·       Support scaling and optimization of high-throughput NGS laboratory workflows

    ·       Contribute to laboratory build-out, workflow standardization, and documentation systems

    ·       Lead assay improvements and platform transitions when required

    ·       Implement process improvements to increase throughput, data quality, and operational efficiency

    Quality & Regulatory Compliance

    ·       Maintain inspection readiness and support CLIA/CAP audits

    ·       Oversee QC monitoring, deviation tracking, and corrective actions

    ·       Participate in validation and verification of new assays and instrumentation

    ·       Ensure rigorous data integrity and standardized documentation practices



    Requirements

    Required Qualifications

    ·       Active California Clinical Genetic Molecular Biologist Scientist (CGMBS) License

    ·       B.S. in Biochemistry, Molecular Biology, or related field

    ·       2+ years of experience in molecular diagnostics or high-complexity CLIA laboratories

    ·       Demonstrated experience establishing or scaling NGS-based clinical testing

    ·       Strong hands-on experience with DNA extraction, sample preparation, and high-throughput NGS platforms

    ·       Deep understanding of CLIA/CAP regulatory standards

    ·       Proven ability to implement process improvements and optimize laboratory operations

    Numbers & Facts

    LocationMilpitas, California

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