Analyst

• Serve as system owner or administrator for lab informatics platforms; handle configurations, access controls, and master data.
• Function as the primary liaison for system-related user support, resolving problems and coordinating partner concerns with IT or vendors.
• Monitor system performance and user experience, implementing improvements and enhancements as needed.
• Develop and maintain dashboards, reports, and data queries to support laboratory operations and decision-making.
• Lead or participate in projects for system upgrades, enhancements, module rollouts, and new implementations.
• Collaborate with collaborators to collect business needs, translate them into functional specifications, and coordinate with IT for implementation.
• Conduct functional testing, support user acceptance testing (UAT), and ensure systems are appropriately validated for use in GxP environments.
• Handle documentation including business process mapping, configuration logs, training materials, and change control records.
• Lead all aspects of developing and completing validation protocols (IQ/OQ/PQ) and coordinate the computerized system validation (CSV) lifecycle.
• Ensure informatics platforms adhere to relevant regulatory standards such as 21 CFR Part 11, GAMP 5, and data integrity ALCOA+ principles.
• Support audit readiness activities by preparing system documentation, conducting internal reviews, and participating in regulatory inspections.
• Maintain audit trails, user access logs, and change records in accordance with quality system procedures.
• Act as a liaison between lab operations, IT, QA, and software vendors to ensure system requirements and project objectives are met.
• Deliver training and onboarding for new users; develop user guides, FAQs, and knowledge base materials.
• Coordinate user group meetings to collect feedback, share guidelines, and encourage ongoing system improvement.
• Lead junior analysts, business users, or contractors who assist with maintaining laboratory information systems.
• Delegate tasks, supervise progress, and provide coaching to support skill development and career growth.
• Develop a collaborative and inclusive work environment focused on operational excellence and innovation.

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