Remote CLIA Compliance Analyst IV

Chenega Professional Services Strategic Business Unit; Georgia; On-site; USD 110,000 - 120,000; Full time

Job summary

Chenega Enterprise Systems & Solutions, LLC (a Chenega Professional Services company) seeks a CLIA Compliance Analyst IV to support the Office of Laboratory Quality (OLQ) at CDC, focusing on CLIA regulations, quality systems, and lab audits.

The role involves remote work with periodic in-person reviews, travel to CDC facilities for annual audits, and collaboration with ID labs to ensure testing quality and regulatory readiness.

Qualifications

• Master’s or Ph.D. in a relevant field.
• 7+ years in a diagnostic laboratory or regulated environment.
• Experience with CLIA regulations and CDC quality standards.

Responsibilities

• Review MV plans, reports, verification studies for CLIA compliance.
• Review SOPs, validation docs, IFUs for consistency with validated methods.
• Provide written feedback to laboratories on deficiencies and regulatory concerns.
• Manage CLIA document control activities and archival to ensure inspection readiness.
• Conduct annual ID laboratory audits across CDC Atlanta ID laboratories.
• Develop tools and resources to support ID laboratory compliance and test directories.
• Prepare and review test method validation studies for performance characteristics.
• Collaborate with OLSR/OLQ and ID leadership to improve quality and communications.

Skills

Quality Assurance

Regulatory compliance

Auditing

Documentation control

Education

Master’s or Ph.D. in Microbiology/Life Sciences

ASCP/AMT/AAB Board Certification preferred

Job description

Chenega Enterprise Systems & Solutions, LLC (a Chenega Professional Services company) seeks a CLIA Compliance Analyst IV to support the Office of Laboratory Quality (OLQ) at CDC, focusing on CLIA regulations, quality systems, and lab audits.

The role involves remote work with periodic in-person reviews, travel to CDC facilities for annual audits, and collaboration with ID labs to ensure testing quality and regulatory readiness.