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 ID laboratory 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, and supporting documentation 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 ID laboratory audits of each of approximately 25 CDC Atlanta ID laboratory branches for adherence to CLIA regulations and QMS to determine potential areas of vulnerabilities that may pose a risk to the agency.   

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

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

• 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, ID laboratory staff and ID laboratory leadership, towards improving overall quality of ID laboratory testing at CDC. The 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 compliancetoqualitystandards, andsupport 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 ID laboratories on corrective actions.  

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

• Review data and evaluate for test specificity, precision, and reproducibility as well as other performance characteristics to confirm test is fit for purpose. Document review process and approvals of assay development and validation data.  

• Makerecommendationswhere physical ID laboratory processes, system and infrastructure requirements, quality management guidelines, and protocols could be updated to mitigate frequency of non-conforming events surrounding ID laboratory data.  

• Maintain the CDC ID Test Directory (client services menu) housed on externally facing CDC servers, initiate test order updates, provide recommendations and solutions to improve the ID test order directory update process and recurring update cycle.  

• Risk Assessment. Identify potential compliance risks and work with relevant departments to develop mitigation strategies. 

• Contractor shall travel to CDC facilities for the purpose of conducting the 25 annual laboratory audits. 

• Other duties as assigned

• Minimum Qualifications:(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.) 

  • Master’sor Ph.D.degree in a relevant fieldMicrobiology, Life Sciences,chemical, physical, biological or clinical laboratory science. 
  • 7+years experiencein a diagnostic laboratory or other similar regulated environment performing or supervising high complexity microbiology with a minimum of 6 months in subspecialty of service.
  • Experience in Method Validations and Verifications, Molecular biology techniques, certified in Molecular Biology, Methods Applied to Research and Clinical Diagnosis, knowledgeable of laboratory compliance issues, Ability to read analyze and interpret general laboratory periodical, Experience writing technical laboratory reports, laboratory procedure manuals, and business correspondence. 
  • Previous auditing experience preferred. At least7+years of experience in a compliance or regulatory role within a clinical laboratory or healthcare setting, with a strong understanding of CLIA regulations. 
  • ASCP, AMT, or AAB Board Certification preferred. 

  Knowledge, Skills and Abilities: 

  • Manage laboratory accreditations and certifications.  
  • Able to understand and apply new regulations.  
  • Experience with or knowledge of Quality Assurance procedures.  
  • Must be attentive to detail and organized, especially related to documentation and record-keeping. 
  • Familiarity with CLIA regulations and standards. 
  • Ability and judgment to interact and communicate appropriately with other employees, clients, and management.
  • Excellent interpersonal, verbal, and written communication skills. Proven track record and experience in building and cultivating strong relationships.
  • Ability to organize data and generate reports.