Quality Assurance Coordinator
Core
Administrator of the laboratory Quality Management System (QMS) ensuring compliance with regulatory standards and accreditation requirements.
Role type
Associate-level Quality Assurance Coordinator
Builds
Quality management processes, documentation, and compliance reports for a DNA diagnostic laboratory
Domain
Life sciences / Clinical diagnostics / Laboratory operations
Deliverable
dashboards & analysis
Required skills
Document control, CAPA management, audit support, regulatory compliance knowledge, data analysis, root cause analysis
Preferred skills
MediaLab or MasterControl proficiency, knowledge of CLIA/CAP/AABB/ISO standards
Technologies
MediaLab, MasterControl, TrackWise, Qualtrax, Microsoft Office
Responsibilities
Coordinate day-to-day QMS operation and maintenance; Manage document control processes including SOP creation and revision tracking; Monitor training assignments and completion; Support internal audits and accreditation activities; Track and document nonconformances and quality events; Coordinate corrective and preventive action (CAPA) activities; Collect, analyze, and report laboratory quality metrics and KPIs
Seniority
Associate, hands-on IC