Clinical Lab QA Specialist – Inspection-Ready

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

Benefits offered by this job

Healthcare

401K

Unlimited PTO

Professional development

Team offsites

Job summary

MyOme seeks a Quality Assurance Specialist to support day‑to‑day QA and compliance for our clinical laboratory. You will maintain quality records, manage controlled documents, and support training, NCRs, and quality metrics.

Reporting to the QA Manager, you will partner with lab operations to ensure organized, accurate, and inspection‑ready records and timely quality deliverables in a regulated environment.

Qualifications

• Bachelor’s degree in biological sciences or equivalent experience.
• At least 2 years of QA in a regulated clinical laboratory.
• Working knowledge of CLIA and CAP requirements; NYS CLEP preferred.
• Hands‑on QA records such as maintenance, training, indicators.
• Experience with NCR/NCM workflows and trend analysis.
• Familiarity with supplier quality records and supplier qualification.
• Experience with controlled documents in a QMS/EDMS.
• Strong organization and ability to manage multiple recurring tasks.

Responsibilities

• Support daily QA activities and maintain inspection readiness (CLIA, CAP, NYS CLEP).
• Review and track quality records, qualification, and calibration docs.
• Coordinate nonconformance reports, investigations, actions, and closure.
• Maintain employee training and competency records, timelines, overdue items.
• Manage document control throughout the lifecycle of policies and SOPs.
• Compile monthly QA reports and quality metrics (TAT, trends, indicators).
• Maintain supplier quality records and qualify suppliers as needed.
• Identify gaps and escalate actions to the QA Manager as required.
• Support inspections, audits, CAPAs, deviations, and change controls.
• Collaborate with operations to keep records complete and inspection‑ready.

Skills

Quality Assurance

Documentation

Regulatory compliance

CAPA processes

QMS

EDMS/eQMS usage

Education

Bachelor’s degree in biological sciences

Tools

eQMS/EDMS

Job description

MyOme seeks a Quality Assurance Specialist to support day‑to‑day QA and compliance for our clinical laboratory. You will maintain quality records, manage controlled documents, and support training, NCRs, and quality metrics.

Reporting to the QA Manager, you will partner with lab operations to ensure organized, accurate, and inspection‑ready records and timely quality deliverables in a regulated environment.