Senior Business Analyst (CLIA-regulated laboratory environment)

Location: San Diego, CA (100% Onsite)
Duration: 1 Year Contract (Extension/Conversion Possible)
Work Schedule: Monday–Friday, 40 Hours/Week

Important: Candidates must have direct experience in a CLIA-regulated laboratory environment and hands-on CSV experience. General healthcare IT, payer, claims, or revenue cycle experience without laboratory operations exposure will not be considered.

Job Overview

• We are seeking an experienced Senior Business Analyst to support Laboratory IT initiatives within a CLIA- and CAP-regulated molecular diagnostics laboratory.
• The candidate will work closely with Laboratory Operations, Quality, Bioinformatics, and IT teams to gather requirements, improve laboratory workflows, support LIS implementations, and manage system validation activities.

Key Responsibilities

• Gather, analyze, and document business and technical requirements.
• Develop user stories, functional requirements, process flows, and acceptance criteria.
• Support Laboratory Information Systems (LIS) enhancements and integrations.
• Work on laboratory system integrations involving EMR/EHR, laboratory instruments, and bioinformatics platforms.
• Support molecular diagnostics, assay onboarding, and NGS workflow initiatives.
• Lead or support Computer System Validation (CSV), including test scripts, validation documentation, and traceability matrices.
• Coordinate User Acceptance Testing (UAT), implementation, and end-user training.
• Ensure compliance with CLIA, CAP, HIPAA, and applicable quality standards.
• Collaborate with laboratory and IT stakeholders to improve workflows and operational efficiency.

Required Qualifications

• Bachelor's degree in Business, IT, Computer Science, Life Sciences, or a related field.
• Minimum 3 years of experience as a Business Analyst, Systems Analyst, or LIS Analyst.
• Minimum 3 years of experience working in a CLIA-regulated laboratory environment.
• Hands-on experience with Computer System Validation (CSV), including validation documentation, test scripts, traceability matrices, and UAT.
• Strong experience in requirements gathering, process mapping, user stories, and functional documentation.
• Knowledge of CLIA, CAP, and HIPAA regulations.
• Excellent communication and stakeholder management skills.
• Must be comfortable working 100% onsite in San Diego, CA.

Preferred Qualifications

• Experience in molecular diagnostics, genomics, oncology, or NGS laboratories.
• CLS/MLS/MT or clinical laboratory background.
• Experience with LIS platforms, particularly SCC Soft Computer.
• Experience with Epic, EMR/EHR integrations, HL7 interfaces, or bioinformatics systems.
• Experience with assay onboarding and laboratory system integrations.
• Experience supporting laboratory mergers, acquisitions, or multi-site integrations.