Clinical Laboratory QA & Regulatory Specialist (Individual Contributor)

SeqMatic LLC. • Fremont, CA

4d • $125,000 - $145,000 • Onsite

About The Position

This is a full-time, in-house individual contributor role based in the company’s Fremont, California laboratory. The specialist will build and scale the quality and regulatory frameworks for novel next-generation sequencing (NGS)-based Laboratory Developed Tests (LDTs), rather than simply maintain an existing corporate compliance program. The role combines hands-on execution with strategic ownership of the clinical laboratory’s compliance infrastructure.

Requirements

• Bachelor’s or Master’s degree in Molecular Biology, Genetics, Bioinformatics, or a closely related life science discipline.
• At least 3 years of direct experience managing regulatory affairs, quality assurance, or high-complexity clinical operations within an active CLIA-certified and CAP-accredited molecular diagnostics laboratory.
• Hands-on familiarity with NGS workflows, wet lab platforms such as Illumina, genomic data integrity standards, and clinical variant classification using ACMG/AMP guidelines.
• Operational understanding of 42 CFR Part 493 (CLIA), CAP general and molecular checklists, California clinical laboratory laws, and the implications of the FDA’s Final Rule on LDT oversight.
• Ability to build processes where none exist, work independently, navigate ambiguity, and personally write protocols and SOPs.
• Exceptional interpersonal and technical writing skills, including the ability to translate complex legal and regulatory requirements into actionable items for scientists and engineers.

Responsibilities

• Lead initial facility registrations and programmatic requirements to secure and maintain CLIA certification, CAP accreditation, and California state clinical laboratory licenses.
• Author, organize, and compile analytical and clinical validation packages for high-complexity NGS assays in compliance with CLIA/CAP guidelines and state frameworks.
• Interpret, strategize, and execute compliance workflows for the FDA’s multi-phase LDT oversight framework, including adverse event reporting, corrections, and future premarket expectations.
• Design, implement, and maintain a lean, scalable Quality Management System (QMS), including writing SOPs, managing document control, overseeing proficiency testing, coordinating training logs, and tracking CAPAs and non-conformances.
• Collaborate with customers and in-house computational biology teams to document and validate clinical bioinformatics pipelines, data integrity protocols, variant filtering parameters, and LIMS workflows.
• Serve as the primary technical point of contact for external audits, California CDPH inspections, and laboratory audits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level