Remote CLIA Compliance Analyst - Lab Audits & Standards

Chenega Professional Services Strategic Business Unit; Atlanta (GA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Chenega Enterprise Systems & Solutions, LLC seeks a CLIA Compliance Analyst IV to support the Office of Laboratory Quality (OLQ) in guiding infectious disease testing at CDC. The role focuses on CLIA compliance, document control, and audits across ~25 CDC Atlanta ID laboratories, with remote work and periodic in-person reviews and travel to CDC facilities.

The ideal candidate has an advanced degree in a relevant field and 7+ years in regulated labs, plus experience with method validations,

Qualifications

• Master’s or Ph.D. in Microbiology, Life Sciences, or related field.
• 7+ years of diagnostic laboratory or regulated environment experience.
• Experience with Method Validations and Verifications; molecular biology techniques.
• Certified in Molecular Biology; knowledge of lab compliance.
• Previous auditing experience preferred.
• ASCP/AMT/AAB certification preferred.

Responsibilities

• Review and evaluate MV plans, reports for CLIA compliance and CDC quality standards.
• Review SOPs, validation docs, IFUs, and supporting records for consistency with approved methods.
• Provide feedback to laboratories on deficiencies, regulatory concerns, and recommendations for compliance.
• Manage CLIA document control activities including creation, revision, approval, and archival.
• Review Document Change Requests (DCRs) and guide laboratories on CLIA document control requirements.
• Conduct annual ID laboratory audits of approximately 25 CDC Atlanta ID laboratory branches.
• Support CDC ID laboratories with consultations and improvements to communication processes.
• Create tools and resources for ID laboratory compliance and the Test Directory.
• Maintain and improve the process for test method validation studies and performance characteristics.
• Travel to CDC facilities for annual laboratory audits.

Skills

Auditing

CLIA regulations

Molecular biology

Quality assurance

Documentation

Regulatory compliance

Communication

Education

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

Job description

Chenega Enterprise Systems & Solutions, LLC seeks a CLIA Compliance Analyst IV to support the Office of Laboratory Quality (OLQ) in guiding infectious disease testing at CDC. The role focuses on CLIA compliance, document control, and audits across ~25 CDC Atlanta ID laboratories, with remote work and periodic in-person reviews and travel to CDC facilities.

The ideal candidate has an advanced degree in a relevant field and 7+ years in regulated labs, plus experience with method validations,