Quality Assurance Specialist

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 escalate 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