Clinical Lab Information Specialist
Core
Lead User Acceptance Testing (UAT), system validation, and regulatory compliance documentation for laboratory information systems to ensure audit readiness and operational alignment.
Role type
Senior Clinical Lab Information Specialist (Regulatory & Validation)
Builds
Validated laboratory information systems (LIS), middleware, and instrument interfaces compliant with GxP, CLIA, CAP, and FDA standards.
Domain
Clinical Laboratory Informatics & Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
UAT leadership and execution, system validation planning (IQ/OQ/PQ), regulatory documentation authoring, business analysis, stakeholder liaison, SOP development, risk assessment, traceability matrix creation
Preferred skills
Epic Beaker, SCC Soft, Sunquest, Cerner Millennium platform experience, HL7 data standards knowledge, audit/inspection readiness, electronic document management systems (eDMS)
Technologies
LIS, LIMS, middleware, instrument interfaces, eDMS
Responsibilities
Lead and coordinate UAT activities for laboratory systems; Plan and execute system validation activities per regulatory standards; Author validation deliverables (VP, URS/FRS, Risk Assessments, IQ/OQ/PQ); Develop and maintain SOPs and quality documentation; Gather and document business requirements from stakeholders; Support audit and inspection activities
Seniority
Senior, hands-on IC