CLIA Compliance Analyst IV (Clinical Laboratory Compliance)

Location: Primarily remote within the United States, with periodic and/or monthly/quarterly in-person meetings and travel to CDC facilities in Atlanta, Georgia

Salary: USD $110,000–$120,000 per year

Company

hirify.global Enterprise Systems & Solutions, part of hirify.global Professional Services, provides professional services supporting public-sector healthcare and infectious disease laboratory programs.

What you will do

• Review method validation plans, reports, verification studies, SOPs, IFUs, and supporting records for compliance with CLIA regulations, CDC quality standards, and internal policies.
• Provide actionable feedback to laboratories, document deficiencies, approve validation data, and support test method implementation.
• Manage CLIA document control, including document creation, revision, approval, version control, archival, and change requests.
• Conduct coordinated CLIA and quality audits across approximately 25 CDC Atlanta infectious disease laboratory branches.
• Support corrective actions, risk assessments, continuous improvement initiatives, external inspections, and regulatory reviews.
• Maintain the CDC ID Test Directory and develop compliance tools, procedures, templates, training, and consultation services.

Requirements

• Master’s or Ph.D. degree in microbiology, life sciences, chemical, physical, biological, or clinical laboratory science.
• 7+ years of experience in a diagnostic laboratory or similar regulated environment, including high-complexity microbiology and at least 6 months in a service subspecialty.
• 7+ years of experience in a compliance or regulatory role within a clinical laboratory or healthcare setting, with strong knowledge of CLIA regulations.
• Experience with method validation and verification, molecular biology techniques, quality assurance, laboratory reports, procedure manuals, and technical correspondence.
• Ability to interpret regulations, organize data, generate reports, maintain records, and communicate effectively with laboratory staff, leadership, clients, and management.
• Ability to travel to CDC facilities and attend periodic in-person meetings in Atlanta, Georgia.

Nice to have

• Previous auditing experience.
• ASCP, AMT, or AAB board certification.

Culture & Benefits

• Remote-focused work arrangement aligned with CDC’s telework posture.
• Regular employee benefits program.
• Management engagement, quality leadership, teamwork, performance recognition, and promotion opportunities.