Backed by Sequoia.
About the role
We are seeking a Quality Assurance Specialist to support the day-to-day quality and compliance activities of our clinical laboratory and help maintain a continuous state of inspection readiness. Reporting to the Quality Assurance Manager, this role will partner closely with laboratory operations and cross-functional teams to maintain quality records, manage controlled documents, support employee training and competency programs, coordinate nonconforming event records, and compile routine quality metrics.
What they're looking for
- Support daily QA activities for clinical laboratory operations and help maintain continuous CLIA, CAP, and NYS CLEP inspection readiness
- Review, maintain, and track quality records, including reagent qualifications, equipment qualification, maintenance and calibration records, and associated documentation
- Coordinate nonconformance reports (NCRs), including intake, documentation, investigation follow-up, action tracking, trending, and timely closure in partnership with the QA Manager and responsible process owners
- Maintain and monitor employee training and competency records, including tracking completion and identifying upcoming or overdue requirements
- Identify documentation gaps, overdue quality activities, and recurring quality issues, track follow-up actions and escalate items requiring investigation or risk-based decisions to the QA Manager
- Partner primarily with laboratory operations and other process owners to maintain complete, timely, and inspection-ready quality records and support consistent execution of established quality procedures
More about this role
MyOme’s mission is to provide clinically actionable genetic information to patients throughout their lives. We combine clinical-grade whole genome sequencing, advanced AI methods for genome interpretation, and seamless digital tools for doctors and patients to order and access results. Our team is composed of seasoned entrepreneurs, scientists, and operators, and we're backed by top-tier investors.
We are seeking a Quality Assurance Specialist to support the day-to-day quality and compliance activities of our clinical laboratory and help maintain a continuous state of inspection readiness. Reporting to the Quality Assurance Manager, this role will partner closely with laboratory operations and cross-functional teams to maintain quality records, manage controlled documents, support employee training and competency programs, coordinate nonconforming event records, and compile routine quality metrics. The ideal candidate has hands-on quality assurance experience in a regulated clinical laboratory and understands what it takes to maintain organized, accurate, compliant, and inspection-ready quality records. This is a hands-on execution-focused role for someone who is detail-oriented,...
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