Quality Assurance Specialist

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

Benefits offered by this job

Healthcare coverage

401K

Unlimited PTO

Professional development

Job summary

MyOme, Inc. in Menlo Park is seeking a Quality Assurance Administrator or Specialist to support day-to-day quality and compliance activities in our clinical laboratory.

You will manage quality records, document controls, training programs, NCRs, and contribute to inspection readiness with cross-functional teams. This hands-on role requires hands-on QA experience in a regulated clinical lab, CLIA/CAP knowledge, and strong organizational skills.

Qualifications

• Bachelor's degree in biological sciences or related field or equivalent experience.
• Strong organizational skills and attention to detail with multiple tasks.
• Clear written and verbal communication with team follow-up.
• QA Administrator: 1-2 years QA in regulated clinical laboratory; CLIA/CAP familiarity.
• QA Specialist: 2-3 years in regulated clinical laboratory; CLIA/CAP knowledge; NYS CLEP preferred; experience with quality records and NCR workflows; EDMS familiarity.

Responsibilities

• Support daily QA activities and maintain inspection readiness.
• Review and maintain quality records and documentation.
• Document NCRs and follow up with owners.
• Maintain training and competency records.
• Perform document control throughout lifecycle.
• Compile monthly QA reporting and quality metrics.
• Maintain supplier quality records and escalate gaps.
• Identify gaps and escalate to QA Manager.
• Assist with inspections and audits; support CAPAs and deviations.

Skills

Quality assurance

Documentation

Communication

Organizational skills

Education

Bachelor's degree in biological sciences or related field

Tools

QMS/EDMS (eQMS) experience

CAP/CLIA knowledge

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 Administrator or 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, document nonconformances, and compile quality metrics. This is a hands-on, detail-oriented role for someone comfortable managing recurring tasks and deadlines. The ideal candidate has hands-on quality assurance experience in a regulated clinical laboratory (level based on experience).

What You’ll Do

• Support daily QA activities for clinical laboratory operations and help maintain CLIA, CAP, and NYS CLEP inspection readiness.
• Review and maintain quality records, including reagent and equipment qualification, maintenance and calibration records, and associated documentation.
• Document and follow up on nonconformance reports (NCRs) with the QA Manager and responsible process owners.
• Maintain 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, revision, 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.
• Maintain supplier quality records, 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.
• Strong organizational skills and attention to detail, with the ability to manage multiple recurring quality activities, deadlines, follow-up actions, and records simultaneously.
• Clear written and verbal communication skills, and comfort following up with team members on outstanding items.
• QA Administrator:
  • 1-2 years of Quality Assurance experience in a regulated clinical laboratory, diagnostic, biotechnology, life sciences, or similarly regulated environment.
  • Familiarity with CLIA and CAP requirements and document control
• QA Specialist:
  • At least 2-3 years 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, and quality indicators.
  • Experience supporting nonconformance/NCR workflows, including documentation, investigation follow-up, action tracking, trending, and closure.
  • Experience handling controlled documents and records within a QMS or electronic document management system (eQMS/EDMS).
  • 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 laboratory campus.
• Compensation: Annual base salary range is $85,000 - $105,000

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