Quality Assurance Coordinator
Core
Ensures laboratory compliance with regulatory, licensing, and accreditation requirements (CLIA, CAP, FDA, ISO) through documentation management, audit coordination, and inspection support.
Role type
Regulatory Affairs Coordinator
Builds
Regulatory readiness and compliance status for laboratory operations
Domain
Life Sciences / Clinical Diagnostics / Laboratory Services
Deliverable
dashboards & analysis
Required skills
Regulatory compliance knowledge, documentation management, audit coordination, data analysis, SOP alignment, incident investigation
Preferred skills
Quality management certification (CQA/Six Sigma), 5-7 years regulatory agency experience
Technologies
LIMS, Microsoft Office Suite
Responsibilities
Interpret and apply federal/state/local regulations; maintain licenses and certifications; coordinate external audits and inspections; perform internal audits; manage SOP alignment; analyze quality data and prepare compliance reports; train staff on regulatory standards.
Seniority
Mid-level, hands-on IC