Clinical Laboratory QA & Regulatory Specialist (Individual Contributor)
SeqMatic LLC. · Posted Nov 6, 2026
- Fremont, California, United States
- On-site
- Full-time
- 3+ years
Lead the development and implementation of compliance infrastructure for a high-complexity NGS laboratory, including CLIA, CAP, and FDA regulatory frameworks.
Responsibilities
- Establish compliance infrastructure and secure CLIA, CAP, and state licenses
- Author and compile LDT validation documentation
- Interpret and execute FDA regulatory workflows
- Design and maintain a lean QMS and SOPs
- Collaborate on bioinformatics and LIMS validation
Requirements
- Bachelor’s or Master’s degree in Molecular Biology, Genetics, Bioinformatics, or a closely related life science discipline