Quality Assurance Specialist

Job Details

• Location:
  
  9165 E Del Camino Dr, Suite 101, Scottsdale, AZ, 85258, United States
• Employee Type:
  Exempt - FT
• Required Degree: 4 Year Degree
• Manage Others:
  No

The Quality Assurance (QA) Specialist I is responsible for supporting and advancing the laboratory’s quality management system through the application of specialized knowledge in laboratory practices, regulatory standards, and quality control procedures. This role evaluates quality data, investigates complex quality issues across all phases of the testing process (pre‑analytic, analytic, and post‑analytic), and determines appropriate corrective and preventive actions (CAPAs) to mitigate risk and ensure compliance.

The QA Specialist I independently analyzes quality metrics and trends, develops reports, and provides recommendations that inform operational and business decisions. This role advises and influences cross‑functional stakeholders and provides authoritative guidance on quality and compliance matters. Through these efforts, the QA Specialist I directly impacts laboratory accreditation and regulatory standing while helping to reduce organizational risk exposure.

The QA Specialist I leads and contributes to cross‑functional initiatives to resolve systemic quality issues and drive continuous improvement. This role authors and maintains standard operating procedures (SOPs), policies, and controlled documentation to ensure alignment with regulatory requirements, including HIPAA, CLIA, CAP, CLEP, OSHA, ISO, FDA, and other applicable standards.

Operating with minimal supervision, the QA Specialist I prioritizes and manages workload based on business needs and risk, serving as a key resource to leadership on quality and regulatory matters. This role supports leadership decision‑making on compliance strategy and operational performance while fostering a culture of quality and continuous improvement across the organization.

• Investigate quality incidents and prepare documentation, including incident reports, deviations, and corrective and preventative action (CAPA) plans.
• Evaluate and resolve complex quality issues impacting compliance and operations.
• Collect and independently analyze QA data and present to leadership.
• Conduct quality metric reviews and corresponding reports related to laboratory quality, including independent evaluation of appropriate corrective actions and advising key stakeholders of corrective action plans.
• Oversee and evaluate laboratory quality control experiments and processes, as needed, and author corresponding reports.
• Effectively monitor and analyze key quality metrics, including report design, graphical display, and analytical interpretation.
• Lead cross‑functional collaboration to ensure timely review and approval of materials.
• Lead desk audits to evaluate ongoing compliance of laboratory accreditation requirements, including CLIA, CAP, and CLEP, and advise key stakeholders on recommendations or improvements.
• Prepare, review, and ensure timely submission of documents to regulatory agencies.
• Participate in both internal and external quality audits.
• Review and update policies and procedures related to quality assurance, including continuous improvement of processes.
• Manage completion of the Alternate Proficiency Assessment (APA) or other Proficiency Testing (PT) as appropriate and author corresponding reports for Medical Director review and approval.
• Review laboratory quality plans and evaluate trends and metrics to maximize performance improvement and error reduction processes; advise key stakeholders and lead implementation of quality plans as appropriate.
• Lead quality initiatives including designing and implementing quality improvement plans.
• Synthesize and present QA data to inform leadership decision‑making.
• Have strong knowledge of HIPAA requirements.
• Audit and enforce compliance with equipment maintenance activities and maintenance records.
• Create and administer quality training, such as good documentation practices, good lab practices, and quality auditing practices.
• Develop, review, and interpret policies and procedures, providing quality‑focused feedback.
• Perform other duties as…