Quality Management Specialist

Lukos; Atlanta (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

Lukos seeks a Quality Management Specialist to drive CLIA-regulated quality systems in clinical or public health laboratories. You will manage eQMS documentation, CAPA investigations, and internal quality assessments, ensuring audit readiness and continuous improvement.

The role requires a BS in a related scientific discipline with 5–8 years of experience, plus knowledge of QMML, CLSI standards, and ISO frameworks.

Qualifications

• Bachelor’s degree in a related scientific discipline with 5–8 years of progressive experience managing quality systems in clinical or public health laboratories.
• In-depth knowledge of CLIA regulations (42 CFR Part 493), CLSI guidelines, and ISO standards (e.g., ISO 15189 or ISO 17025).
• Experience establishing and maintaining eQMS platforms such as MasterControl, Qualio, or Veeva, with strict change‑control for SOPs.
• Proven ability to draft, review, archive, and control SOPs, policies, and revision histories under strict change‑control.
• Experience coordinating nonconformance events, NCs, deviations, and OOS investigations.

Responsibilities

• Collaborate with quality and safety managers to implement and manage QMS and CLIA.
• Maintain status and progress of the QMS, QMML, CLIA, CLSI, and related standards.
• Ensure implementation of quality policies using the 12 Quality System Essentials (QSEs).
• Conduct document control and support the management of quality‑related procedures.
• Manage eQMS documents, records, and vendor communications.
• Coordinate with branch personnel and CDC offices on procedures and schedules.
• Administer equipment maintenance and calibration, including vendor quotes and service calls.
• Investigate nonconformances and implement corrective actions.
• Conduct quality assessments to evaluate compliance with policies and standards.

Skills

Quality systems management

Root Cause Analysis

CAPA implementation

SOP drafting and control

Regulatory compliance knowledge (CLIA,

Education

Bachelor’s Degree in related scientific discipline

Master’s Degree preferred

Tools

MasterControl

Qualio

Veeva

Job description

Quality Management Specialist

Minimum Qualifications Summary

• Certification & 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‑compliance 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 Objective

Lukos 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 Location

Atlanta, GA

About Lukos

Lukos delivers professional services to the Department of Defense. Lukos has been one of the most successful and most diversified support companies for US Special Operations Command and its components for over a decade. Since our founding, we have grown to support all military services and multiple federal civilian agencies. About Our Name: Lukos is ancient Greek for “wolf”. The characteristics of the wolf match our approach to national security. The wolf is known for cunning, aggression, patience, and teamwork. An individual wolf is smart, strong, and resilient, but the true strength of wolves is their ability to work together as a wolfpack. Kipling said it best in The Law of the Jungle. For the strength of the pack is the wolf, and the strength of the wolf is the pack. Lukos is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or national origin.