CLIA Compliance Analyst IV

Overview

Come join a company that strives for Extraordinary People and Exceptional Performance!

Chenega Enterprise Systems & Solutions, LLC, a Chenega Professional Services
’ company, is looking for a CLIA Compliance AnalystIV
to support the Office of Laboratory Quality (OLQ) which provides strategic guidance and leadership on infectious disease issues, managing the operations of various centers, including the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), and the National Center for Immunization and Respiratory Diseases (NCIRD).

Our company offers employees the opportunity to join a team where there is a robust employee benefits program, management engagement, quality leadership, an atmosphere of teamwork, recognition for performance, and promotion opportunities. We actively strive to channel ourhighly engagedemployee’sknowledge, critical thinking, innovative solutions for our clients.

Work Location:

Due to CDC’s telework posture, work will be primarily performed in a remote environment for the foreseeable future, with periodic and/or monthly/quarterly in-person meetings, and in-person internal assessments of  documents and records. The primary location address is: 1600 Clifton Rd NE, Roybal Campus, Atlanta, GA 30329

Duties and Responsibilities:

• Review and evaluate Method Validation (MV) plans, reports, verification studies, andsupportingdocumentation to determine compliance with applicable CLIA regulations, CDC quality standards, and internal policies prior to implementation of new or modified test systems.

• Review associated Standard Operating Procedures (SOPs), validation documentation, Instructions for Use (IFUs), and supporting records to ensure consistency with approved laboratory practices and validated methods.

• Provide clear, accurate, and actionable written feedback to laboratories regarding method validation submissions, identifying deficiencies, required revisions, regulatory concerns, and recommendations for achieving compliance with CLIA regulations and CDC quality standards.

• Manage CLIA document control activities, including document creation, revision, approval, version control, and archival to ensure regulatory compliance and inspection readiness.

• Review Document Change Requests (DCRs), maintain document control records, and provide guidance to laboratories on CLIA document control requirements and change management processes.

• Conduct annual  audits of each of approximately 25 CDC Atlanta  branches for adherence to CLIA regulations and QMS to determine potential areas of vulnerabilities that may pose a risk to the agency.

• Support CDC  through maintaining and improving internal consultation services (e.g., e-mail, Microsoft Form submission), providing actionable feedback to stakeholders ( staff,  leadership and OLSR/OLQ).

• Assist with the creation of tools and resources (e.g., procedures, forms, templates) for  compliance and the Test Directory (client services menu) that support standardization throughout CDC .

• Maintain and improve the process for submission, review, and approval of test method validation studies to establish test performance characteristics (e.g., specificity, precision, reproducibility) for clinical and surveillance test systems.

• Work withtasklead to maintain and improve communication processes between OLSR/OLQ,  staff and  leadership, towards improving overall quality of  testing  contractor shall develop solutions that improve communication and customer service to testing laboratories.

• Develop CLIA-related documents and processes, support external inspections, and develop CLIA-related training for laboratory staff.

• Create tools and resources for compliance to quality standards, and support laboratories with consultations.

• Conduct coordinated CLIA and quality audits for adherence to CLIA regulations and CDC quality standards, develop and support external reviews and findings, work with  on corrective actions.

• Collaborate with laboratory management to implement corrective actions and continuous improvement initiatives based on audit findings and…