Quality Assurance Specialist

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, organized, and comfortable managing recurring quality activities and deadlines.

• 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.
• Perform document control activities throughout the document lifecycle, including routing for review and approval, issuance, periodic review tracking, revision, distribution, archival, and retirement of policies, SOPs, forms, and other controlled documents.
• Compile and support monthly QA reporting and quality metrics, including turnaround time (TAT), sequencing and laboratory quality metrics, report revisions/corrections, NCR trends, training compliance, and other quality indicators.
• Maintain supplier quality records and support routine supplier qualification and periodic review activities, including collecting required documentation, tracking due dates, and escalating gaps or issues to the QA Manager.
• Identify documentation gaps, overdue quality activities, and recurring quality issues; track follow‑up actions and elevate items requiring investigation or risk‑based decisions to the QA Manager.
• Support laboratory inspections and audits by organizing records, retrieving objective evidence, tracking requests and responses, and supporting follow‑up activities. Provide administrative and documentation support for CAPAs, deviations, change controls, and other quality records as assigned.
• 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.

• Bachelor's degree in biological sciences, medical technology/clinical laboratory science, quality, or a related scientific discipline, or equivalent relevant experience.
• At least 2 years of Quality Assurance experience in a regulated clinical laboratory, diagnostic, biotechnology, life sciences, or similarly regulated environment.
• Working knowledge of CLIA and…