Quality Management Specialist — CLIA/QMS Leader

Lukos LLC.; Atlanta (GA); On-site; USD 95,000 - 150,000; Full time

Job summary

Lukos seeks a Quality Management Specialist to drive compliance and operational excellence in clinical and research laboratories, leveraging CLIA regulations, CDC QMML standards, and the 12 QSEs. The role manages eQMS document control, CAPA investigations, and internal quality assessments within high-complexity lab environments.

Responsibilities include coordinating vendor service calls, equipment maintenance, and cross-functional communication to ensure audit readiness and regulatory adherence

Qualifications

• 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 mapping QMS to CLSI 12 QSE model and adherence to ISO standards.

Responsibilities

• Collaborate with QA and safety to implement and manage QMS and CLIA.
• Maintain knowledge of QMS, QMML, CLIA, CLSI, and applicable standards and their implementation.
• Ensure and manage the effective implementation of quality policies using the 12 QSEs.
• Perform document control and support management of quality-related procedures and forms.
• Maintain, update, and track documents in CDC’s eQMS.
• Coordinate with branch personnel and CDC offices on procedures and schedules.
• Administer equipment maintenance and calibration activities, including vendor quotes and CDC procurement processes.
• Investigate nonconformance events and develop corrective actions.
• Conduct quality assessments to evaluate compliance with policies and standards.

Skills

CLIA regulations

QMS implementation

eQMS administration

CAPA

Root Cause Analysis

Document control

Audits

Vendor management

Education

B.S. in science

Master’s degree preferred

Tools

MasterControl

Qualio

Veeva

Job description

Lukos seeks a Quality Management Specialist to drive compliance and operational excellence in clinical and research laboratories, leveraging CLIA regulations, CDC QMML standards, and the 12 QSEs. The role manages eQMS document control, CAPA investigations, and internal quality assessments within high-complexity lab environments.

Responsibilities include coordinating vendor service calls, equipment maintenance, and cross-functional communication to ensure audit readiness and regulatory adherence