Quality Assurance Specialist
Core
Provide comprehensive laboratory quality assurance, quality management system (QMS), and safety program support for the CDC's Coronavirus and Other Respiratory Viruses Division.
Role type
Quality Assurance Specialist (Laboratory Operations)
Builds
Laboratory quality initiatives and regulatory compliance for federal health agencies
Domain
Public Health / Clinical Laboratory Science
Deliverable
physical/clinical work
Required skills
Quality Management Systems (QMS), CAPA Management, Risk Assessment & Mitigation, Audit & Inspection Readiness, CMS/CLIA Compliance, Biosafety & Laboratory Safety Programs, Equipment Lifecycle Management, Temperature Monitoring Systems, SOP Development & Document Control, Quality Metrics & Reporting
Preferred skills
Master's degree in Life Sciences, Medical Technologist (MT) or equivalent certification, Experience in CLIA/CAP/ISO-regulated environments
Technologies
MESA (Temperature Monitoring Systems)
Responsibilities
Support implementation and maintenance of Laboratory Quality Management Systems (QMS); Conduct quality assessments, gap analyses, and corrective action follow-up; Review and monitor Non-Conforming Events (NCEs) and quality performance metrics; Coordinate laboratory audit readiness activities; Manage laboratory temperature monitoring and environmental control programs; Maintain equipment inventories and support calibration/preventive maintenance; Support laboratory safety programs through compliance monitoring and incident investigations; Develop and maintain quality and safety Standard Operating Procedures (SOPs); Conduct risk assessments and recommend mitigation strategies
Seniority
Mid-level, hands-on IC