Manager, Laboratory Quality Assurance

Overview

Under the direction of the Director of Laboratory Services, the Laboratory Quality Assurance Manager will spearhead the quality plan development and oversight of a multi-site CLIA program. They will specifically focus on the maintenance of Point-of-Care Testing (POCT) at clinic locations, reference laboratory workflows, and quality assurance activities for all CLIA testing performed by the organization. The role manages a team of MA (Medical Assistant) CLIA Auditors, ensuring that all testing performed in the clinics meets federal, state, and institutional standards, and collaborates with the laboratory operations team to oversee all CLIA testing quality assurance activities, ensuring regulatory and facility policies are met. The Laboratory Quality Assurance Manager develops and maintains quality program documentation required for CLIA testing that the organization performs. The primary goal is to maintain high integrity and quality testing while maintaining a constant state of audit-readiness.

Responsibilities

Essential Functions:

• Serve as the primary quality lead for CLIA testing, ensuring adherence to personnel qualifications, proficiency testing, validation protocols, and quality regulatory requirements.
• Standardize POCT procedures across all clinical sites to ensure uniformity in patient care and regulatory compliance.
• Oversee the validation and implementation of new diagnostic instrumentation and test menus in coordination with the laboratory management and operations teams.
• Aid in competency assessment adherence and coordinate with education teams.
• Directly manage and mentor a team of CLIA MA Auditors, overseeing site visit schedules and reviewing their audit findings.
• Enhance and maintain standardized audit checklists for laboratory services to use during self-inspections of CLIA testing areas.
• Conduct “audits of the auditors” to ensure consistency in how compliance is measured across the organization.
• Design and implement a comprehensive QMS for laboratory services.
• Monitor and report on laboratory KPIs.
• Lead the laboratory through initial and biennial CLIA/CAP/JC inspections.
• Develop an effective self-inspection audit cadence and adjust as necessary.
• Review quality metrics and findings with clinical leadership and contribute to quality control projects.
• Other job functions as may be needed.

Knowledge, Skills and Abilities:

• Expert level understanding of CLIA regulations and documentation requirements.
• Ability to assess clinical workflows and identify risks or gaps.
• Detail-oriented with strong documentation, organizational, and communication skills.
• Proven experience managing direct reports.
• Comfortable educating peers and leading training sessions.
• Proficient in Microsoft Office Suite, EHR systems, and audit tracking tools.

Qualifications

Minimum Education:

• Associates Degree (higher degree accepted) Medical Technolgoy or Biological Science

Minimum Experience:

• 4 years Clinical Lab Experience

Preferred Licenses and Certifications:

• MLS(ASCP) Medical Laboratory Scientist Upon Hire Preferred
• MLT(ASCP) Medical Laboratory Technician Upon Hire Preferred
• CQA (ASQ) Certified Quality Auditor Upon Hire Preferred