Quality Assurance Specialist

About the role

MyOme’s mission is to provide clinically actionable genetic information to patients throughout their lives. The company combines clinical-grade whole genome sequencing, advanced AI methods for genome interpretation, and digital tools for doctors and patients to order and access results.

MyOme is seeking a Quality Assurance Specialist to support day-to-day quality and compliance activities in its clinical laboratory and help maintain continuous inspection readiness. Reporting to the Quality Assurance Manager, this hands-on, execution-focused role partners with laboratory operations and cross-functional teams.

Responsibilities

• Support daily quality assurance 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, including intake, documentation, investigation follow-up, action tracking, trending, and timely closure with the QA Manager and responsible process owners.
• Maintain and monitor employee training and competency records, track completion, and identify upcoming or overdue requirements.
• Perform document control.

Requirements

• Hands-on quality assurance experience in a regulated clinical laboratory.
• Understanding of maintaining organized, accurate, compliant, and inspection-ready quality records.
• Detail-oriented and organized, with comfort managing recurring quality activities and deadlines.

Key facts

• Supports day-to-day quality and compliance activities in MyOme’s clinical laboratory.
• Helps maintain continuous CLIA, CAP, and NYS CLEP inspection readiness.
• Requires hands-on quality assurance experience in a regulated clinical laboratory.