LIMS Analyst

Key Responsibilities Implement, configure, and maintain LIMS applications to support laboratory and business processes. Gather and analyze user requirements and translate them into system configurations and enhancements. Provide day-to-day support, troubleshooting, incident resolution, and system administration activities. Configure laboratory workflows, sample management processes, test methods, and reporting requirements. Perform system testing, UAT support, and deployment activities for enhancements and upgrades. Collaborate with QA, laboratory, and IT teams to ensure system reliability and compliance. Prepare, review, and maintain validation documentation including URS, FRS, IQ, OQ, PQ, RTM, and other validation deliverables. Support change control, deviation management, CAPA, and periodic review activities. Ensure compliance with applicable regulatory standards such as GxP, FDA 21 CFR Part 11, GAMP 5, and ALCOA+ principles. Participate in audits, inspections, and compliance assessments. Create and maintain SOPs, work instructions, and system documentation. Provide user training and knowledge transfer to laboratory and business teams. Technical Skills Hands-on experience with LIMS platforms such as LabWare, LabVantage, STARLIMS, Thermo SampleManager, or equivalent. Experience in implementing, configuring, supporting, and maintaining LIMS solutions. [Details of...MS Analyst | Outlook] Strong understanding of laboratory workflows and sample lifecycle management. Knowledge of SQL, databases, and system integrations. Experience with incident management, change management, and release processes. Understanding of software development and validation lifecycles. Domain Knowledge Pharmaceutical, Healthcare, Life Sciences, Biotechnology, or Laboratory domain experience. [Details of...MS Analyst | Outlook] Good understanding of GxP regulations and computerized system validation practices. Familiarity with regulatory expectations including FDA 21 CFR Part 11 and GAMP 5. Qualifications Bachelor's degree in Computer Science, Information Technology, Biotechnology, Life Sciences, Pharmacy, or a related discipline. 3-5 years of relevant LIMS experience in a regulated environment.