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AS
Clinical Laboratory Scientist
AccuScan Sciences · Milpitas, California, United States
About The Role
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
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
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