Clinical Laboratory Scientist

Key Responsibilities: Clinical Operations & High-Complexity TestingPerform 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 & OptimizationSupport 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 ComplianceMaintain 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

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