Quality Management SpecialistMinimum Qualifications SummaryCertification & Education - Bachelor's Degree (B.S.) in a related scientific discipline with 5-8+ years of progressive experience managing quality systems in clinical or public health laboratories.
- Master's Degree Preferred
Experience Required - In-depth, working knowledge of CLIA regulations (42 CFR Part 493) for high-complexity testing, as well as CLSI guidelines.
- Hands-on experience building, implementing, and maintaining a QMS mapped directly to the CLSI 12 QSE model (Organization, Process Control, Equipment, Assessment, Occurrence Management, etc.) with CDC's Quality Manual for Microbiological Laboratories (QMML), BSL-2/BSL-3 containment practices, and ISO standards (such as ISO 15189 or ISO 17025).
- Practical experience administering electronic Quality Management Systems (eQMS) such as MasterControl, Qualio, Veeva, or proprietary federal/CDC eQMS platforms.
- Proven track record in drafting, reviewing, archiving, and controlling Standard Operating Procedures (SOPs), policies, forms, and revision histories under strict change-control rules.
- Experience logging, investigating, and resolving Nonconformance Events (NCs), deviations, and out-of-specification (OOS) results.
- Proficiency using structured Root Cause Analysis (RCA) tools (e.g., 5 Whys, Fishbone/Ishikawa diagrams) to develop and monitor Corrective and Preventive Actions (CAPAs).
- Hands-on experience creating audit checklists, scheduling, conducting internal quality assessments, and reporting findings for both clinical and research laboratory workflows.
- Experience preparing laboratories for external accreditation audits (e.g., CLIA, CAP, ISO, or CDC internal oversight).
- Experience coordinating vendor service calls, managing preventative maintenance (PM) schedules, equipment calibrations, and maintaining equipment logbooks.
- Familiarity with vendor contracting, obtaining quotes, and navigating institutional or federal procurement systems (e.g., CDC purchasing workflows and requisition portals implied by this contract specification).
Job ObjectiveLukos seeks a Quality Management Specialist seeking to leverage expertise in CLIA regulations, CDC QMML standards, and the 12 Quality System Essentials (QSEs) to drive compliance and operational excellence in clinical and research laboratories. Proficient in managing eQMS document control, conducting root-cause nonconformance investigations (CAPA), and leading internal quality assessments. Adept at administering equipment maintenance logistics, vendor contracts, and cross-functional communication to maintain seamless laboratory operations. Committed to delivering rigorous regulatory adherence, process optimization, and constant audit readiness within high-complexity laboratory environments.
Responsibilities - Collaborate with the quality manager and safety manager as a team to implement and manage QMS and CLIA.
- Maintain current knowledge of the status, issues, training, and progress related to the Quality Management System (QMS), CDC's Quality Manual for Microbiological Laboratories (QMML), Clinical Laboratory Improvement Amendments (CLIA), Clinical and Laboratory Standards Institute (CLSI), and other applicable national and international standards, including their implementation and ongoing maintenance.
- Ensure and manage the effective implementation of quality policies, processes, and procedures utilizing the 12 Quality System Essentials (QSEs).
- Perform document control and support the management of quality-related procedures and forms.
- Maintain, update, and track documents and records utilizing CDC's electronic quality management system (eQMS).
- Coordinate and communicate with branch personnel and relevant CDC offices regarding procedures, schedules, and related matters.
- Perform administration of equipment maintenance and calibration activities, including obtaining vendor quotes, submitting and managing forms and requests through CDC's applicable purchase systems, and arranging vendor service calls.
- Investigate nonconformance events and develop and implement corrective actions.
- Conduct quality assessments in accordance with quality review plan criteria to evaluate compliance with applicable research and clinical laboratory policies, processes, procedures, and standards.
Education & Certification - Bachelor's Degree (B.S.) in a related scientific discipline with 5-8+ years of progressive experience managing quality systems in clinical or public health laboratories.
- Master's Degree Preferred
Work LocationAtlanta, GA
