CLIA Compliance Task Manager at Chenega Corporation

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 Task Manager to support the Laboratory Quality Office (LQO) 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). The purpose of this role is to provide quality management support

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 our highly engaged employee’s knowledge, critical thinking, innovative solutions for our clients.

Responsibilities

• Monitor CLIA compliance and records maintenance to support external CLIA certification surveys of CDC ID laboratories.
• Directly supervise and mentor a team of CLIA Compliance Analysts, including managing workloads, providing guidance, and facilitating professional development.
• Advise the Laboratory Quality Office, Office of Laboratory Science and Safety of non-compliance, recommend corrective actions, and coordinate appropriate training for ID laboratory staff (e.g., through OLSS/LQO process-specific training, and support of OLSS/LQO monthly sessions for internal staff).
• Conduct regular performance evaluations and provide constructive feedback to ensure high levels of performance and compliance.
• Coordinate activities with analysis team to who will conduct the 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 OLSS/LQO).
• Create 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.
• Maintain and improve communication processes between OLSS/LQO, 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.
• Coordinate laboratory activities to ensure all aspects of testing and reporting meet CLIA standards. Act as the primary liaison between the laboratory and regulatory bodies, addressing any compliance-related inquiries or issues.
• CLIA compliance support. 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.
• Ensure that the analyst team coordinate 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.
• Partner with laboratory management to apply corrective measures and advance improvement efforts in response to audit results and updates in regulations.
• ID laboratory test characterization support. 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.
• Data support. Make recommendations where 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.
• Test directory support. 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 evaluation. Detect potential compliance issues and collaborate with relevant teams to create and implement strategies to address and reduce these risks.
• Contractor shall travel to CDC facilities for the purpose of conducting the 25 annual laboratory audits.
• Other duties as assigned

Qualifications

• Doctorate in chemical, physical, biologica, or clinical laboratory science
• HCLD Board Certification from a U.S. Department of Health & Human Services approved board
• 10+ years experience in a laboratory or other similar regulated environment.
• 10+ years of experience in a compliance or regulatory role within a clinical laboratory or healthcare setting, with a strong understanding of CLIA regulations.
• Previous auditing experience preferred.

Knowledge, Skills and Abilities:

• In-depth understanding of CLIA regulatory requirements .
• Comprehensive knowledge of CLIA regulations, laboratory quality control procedures, and risk management strategies.
• Strong decision making skills
• Proficient computer skills with strong working knowledge in Microsoft Office (i.e. Word, Excel, etc.)
• Strong attention to detail, planning and organizational skills, and have the ability to work efficiently both in a team environment and independently
• Build and maintain a Quality Management System
• Perform internal audits and work with external auditors
• Manage laboratory accreditations and certifications (CLIA)