*** U.S. Residents Only -- No Sponsorship ***
Clinical Laboratory Scientist
California CLS license REQUIRED – Generalist or CGMBS
Full-Time, Direct-Hire, Onsite in Milpitas
Monday–Friday 8am–4:30pm
$60–$67/hour (based on exp)
Required Qualifications:
- Active California CLS license as a Generalist or Clinical Genetic Molecular Biologist Scientist (CGMBS).
- B.S. in Biochemistry, Molecular Biology, or related field.
- 3+ 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.
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