Quality Assurance Specialist

MyOme; Menlo Park (CA); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Healthcare coverage

401K

Unlimited PTO

Professional development

Off-sites and team meals

Direct access to leadership

Job summary

MyOme in Menlo Park, CA is seeking a Quality Assurance Specialist to support QA and compliance in our clinical laboratory, reporting to the QA Manager. You will partner with lab operations to maintain inspection‑readiness records, document control, and quality metrics.

The role requires hands‑on QA in a regulated environment with CLIA/CAPA knowledge, NCR workflows, CAPAs, and EDMS/QMS experience. You will organize records, support audits, and drive timely closure of quality issues.

Qualifications

• Bachelor's degree in biological sciences or related discipline.
• At least 2 years QA experience in a regulated clinical laboratory.
• Working knowledge of CLIA and CAP requirements; NYS CLEP preferred.
• Hands-on QA records management and document control.
• Experience with NCR workflows and CAPA processes.
• Experience with QMS/eQMS and supplier quality records.
• Strong organization and attention to detail.
• Ability to support regulatory inspections and audits.

Responsibilities

• Support daily QA activities for clinical lab operations and inspection readiness.
• Review and track quality records, equipment maintenance, and qualification docs.
• Coordinate NCRs from intake to closure with owners.
• Maintain training and competency records and track upcoming requirements.
• Manage document-control lifecycle for policies and SOPs.
• Compile monthly QA reporting and quality metrics.
• Maintain supplier quality records and qualification activities.
• Identify gaps and escalate items to the QA Manager.
• Support inspections and audits with records retrieval and CAPA support.
• Partner with lab operations to ensure compliant records.

Skills

QA in regulated lab

CLIA/CAP experience

Documentation control

NCR management

QMS/EDMS

Training & competency

Education

Bachelor's degree in biological sciences

Tools

eQMS/EDMS

CAPA system

Job description

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.

Position Overview

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.

What You'll Do

• 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.

What You'll Need

• 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 CAP requirements and experience supporting quality activities within a clinical laboratory; experience with NYS CLEP is strongly preferred.
• Hands‑on experience with clinical laboratory quality records such as equipment maintenance/calibration, reagent qualification, personnel training and competency, quality indicators, document control, and inspection readiness.
• Experience supporting nonconformance/NCR workflows, including documentation, investigation follow‑up, action tracking, trending, and closure.
• Experience maintaining supplier or vendor quality records and supporting qualification or periodic review activities is preferred.
• Experience managing controlled documents and records within a QMS or electronic document management system (eQMS/EDMS).
• Strong organizational skills and attention to detail, with the ability to manage multiple recurring quality activities, deadlines, follow‑up actions and records simultaneously.
• Ability to compile and review routine quality data, identify apparent trends or gaps, and clearly communicate findings to the QA Manager and laboratory stakeholders.
• Experience supporting regulatory inspections, internal audits, CAPAs, deviations, change control, or similar quality documentation activities is preferred.

Location, Compensation, and Benefits

• Location: Onsite at our Menlo Park, CA office.
• Compensation: Annual base salary range is $XXX - $XXX

San Francisco Bay Area pay range: $85,000 USD - $105,000 USD

Benefits

• Comprehensive healthcare coverage (Health, Dental, and Vision)
• 401K
• Unlimited PTO
• Professional development opportunities
• Company-sponsored off‑sites and team meals during in‑person meetings
• Direct access to company leadership and the opportunity for career growth

Diversity, Inclusion, and Equal Opportunity

MyOme values diversity in all forms. We believe that diverse perspectives drive better science and better patient outcomes. We are an Equal Opportunity Employer committed to creating an inclusive workplace that empowers every individual.

Why Work at MyOme

Join us if you

• Want to make an impact at the intersection of healthcare and technology, changing the way people engage with their health at the genetic level
• Enjoy rolling up your sleeves, taking initiative, and being empowered to lead
• Value humility, transparency, and collaborative problem‑solving
• Thrive in fast-moving, dynamic environments with smart, driven teammates
• Appreciate competitive compensation, meaningful equity, and excellent benefits

Learn More: myome.com