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Clinical Laboratory Scientist

CLS Connect · Milpitas, CA

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Clinical Operations & High-Complexity TestingPerform and oversee high-complexity molecular testing including DNA extraction, sample preparation, and NGS workflowsReview and verify test results according to laboratory SOPs and regulatory requirementsEnsure compliance with CLIA, CAP, and California Department of Public Health regulationsLaboratory Build & OptimizationSupport scaling and optimization of high-throughput NGS laboratory workflowsContribute to laboratory build-out, workflow standardization, and documentation systemsLead assay improvements and platform transitions when requiredImplement process improvements to increase throughput, data quality, and operational efficiencyQuality & Regulatory ComplianceMaintain inspection readiness and support CLIA/CAP auditsOversee QC monitoring, deviation tracking, and corrective actionsParticipate in validation and verification of new assays and instrumentationEnsure rigorous data integrity and standardized documentation practicesRequired QualificationsActive California Clinical Genetic Molecular Biologist Scientist (CGMBS) or California Generalist LicenseB.S. in Biochemistry, Molecular Biology, or related field3+ years of experience in molecular diagnostics or high-complexity CLIA laboratoriesDemonstrated experience establishing or scaling NGS-based clinical testingStrong hands-on experience with DNA extraction, sample preparation, and high-throughput NGS platformsDeep understanding of CLIA/CAP regulatory standards