Quality Assurance & Lab Compliance Specialist

Seneca Holdings; Atlanta (GA); On-site; USD 75,000 - 110,000; Full time

Job summary

Great Hill Solutions, LLC seeks a Quality Assurance Specialist in Atlanta, GA to manage laboratory quality assurance, QMS, and safety programs for CDC CORVD initiatives. This role ensures compliance with CDC policies, promotes continuous quality improvement, and collaborates with lab personnel, safety officers, and leadership.

The position requires a Bachelor's in a related field, preferred MT/MLS/CLS certification, and prior experience in CLIA/CMS/CAP or ISO environments.

Qualifications

• Bachelor's degree in Medical Laboratory Science or related field.
• Master's degree preferred.
• Certification as MT, MLS, CLS, or equivalent preferred.
• Experience in CLIA, CMS, CAP, or ISO-regulated labs desirable.

Responsibilities

• Support implementation and improvement of Laboratory Quality Management Systems to ensure regulatory compliance.
• Conduct quality assessments, gap analyses, compliance reviews, and corrective actions.
• Review/non-conforming events, deviations, CAPA, and performance metrics.
• Coordinate audit readiness activities including inspections and documentation.
• Manage laboratory temperature monitoring and environmental control programs.
• Maintain equipment inventories and calibration/maintenance planning.
• Support laboratory safety programs and incident investigations.
• Develop and maintain SOPs, policies, and controlled docs.
• Provide quality and safety training, and participate in improvement groups.
• Perform risk assessments and mitigate quality and safety risks.

Skills

QMS

CAPA Management

Audit & Inspection Readiness

CMS/CLIA Compliance

Biosafety & Safety Programs

Equipment Lifecycle

Temperature Monitoring

SOP Development

Quality Metrics & Reporting

Regulatory Compliance

Security Clearance

Education

Bachelor's degree in Medical Laboratory Science or related field

Master's degree preferred

Certification as MT/MLS/CLS preferred

Experience in CLIA/CMS/CAP or ISO labs desirable

Job description

Great Hill Solutions, LLC seeks a Quality Assurance Specialist in Atlanta, GA to manage laboratory quality assurance, QMS, and safety programs for CDC CORVD initiatives. This role ensures compliance with CDC policies, promotes continuous quality improvement, and collaborates with lab personnel, safety officers, and leadership.

The position requires a Bachelor's in a related field, preferred MT/MLS/CLS certification, and prior experience in CLIA/CMS/CAP or ISO environments.