Senior Business Analyst

Main Duties & Responsibilities

• Lead and coordinate User Acceptance Testing (UAT) activities for laboratory information systems (LIS), middleware, instrumentation interfaces, and other clinical lab technologies
• Develop UAT strategies, test plans, scripts, and acceptance criteria aligned with business and regulatory requirements
• Partner with laboratory stakeholders to ensure test scenarios reflect real-world workflows and operational use cases
• Facilitate defect tracking, triage, and resolution in collaboration with IT and vendors
• Ensure traceability between requirements, test cases, and outcomes
• Plan and execute system validation activities in accordance with regulatory standards (e.g., GxP, FDA 21 CFR Part 11, CLIA, CAP)
• Author and/or review validation deliverables, including:
  • Validation Plans (VP)
  • Requirements Specifications (URS/FRS)
  • Risk Assessments
  • IQ/OQ/PQ protocols and reports
  • Traceability matrices
• Ensure systems are audit-ready and compliant with internal quality systems and external regulatory expectations
• Support audit and inspection activities, including responses and corrective actions
• Gather, analyze, and document business and functional requirements from laboratory stakeholders
• Translate complex laboratory workflows into system requirements and technical specifications
• Serve as a liaison between laboratory operations, IT, vendors, and quality teams
• Facilitate workshops, meetings, and process mapping sessions
• Support system implementation, upgrades, and enhancements across laboratory platforms
• Identify opportunities to improve efficiency, data integrity, and compliance through system optimization

Education & Experience

• Minimum Education & Experience:
  • Bachelor’s Degree or Master Degree in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field required
  • 5-8 years of related experience in clinical laboratory operations, laboratory informatics, or business analysis
  • Strong experience with laboratory systems (LIS, LIMS, middleware, instrument interfaces)
  • Demonstrated expertise in UAT coordination and execution
  • Hands-on experience with system validation in regulated environments (GxP, CLIA, CAP, FDA)
  • Experience authoring validation and regulatory documentation
• Preferred Education & Experience (optional):
  • Experience with specific LIS platforms (e.g., Epic Beaker, SCC Soft, Sunquest, Cerner Millennium)
  • Familiarity with data standards (HL7, interfaces, instrument connectivity)
  • Experience in audit/inspection readiness and regulatory submissions
  • Knowledge of electronic document management systems (eDMS) and change control processes

Reasonable estimate of the current range