Quality Assurance Specialist

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 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.
• 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