Lab QA Coordinator
Core
Administer and maintain the laboratory Quality Management System (QMS) to ensure regulatory compliance and continuous improvement in a regulated diagnostic environment.
Role type
Associate-level Lab QA Coordinator
Builds
Quality management processes, documentation, and compliance reports for a DNA diagnostics laboratory
Domain
Healthcare diagnostics / Laboratory operations / Regulatory compliance
Deliverable
dashboards & analysis
Required skills
Document control, CAPA management, audit support, training compliance, root cause analysis, quality metrics reporting, regulatory standards knowledge (CLIA, CAP, AABB, ISO)
Preferred skills
MediaLab/MasterControl/TrackWise proficiency, vendor qualification support, process streamlining
Responsibilities
Coordinate QMS operations, manage SOP creation and revision tracking, monitor training assignments, support internal audits, track nonconformances and incidents, facilitate quality meetings, assist with root cause analyses, collect and report quality metrics
Seniority
Associate, hands-on IC