IT Support Analyst (GxP, 21 CFR) at Confidential Client (C2C)

IT Support Analyst ( GxP, 21 CFR ) Boston, MA Contract Job description: Waters Empower application support, Empower administration, L1/L2/L3 AMS support, incident management, change management, problem management, ITIL processes, user access management, roles/privileges, project creation, sample set/sample creation, batch creation, instrument connectivity, instrument integration, acquisition nodes, client/server troubleshooting, chromatography data systems, chromatographic integration, GxP, 21 CFR Part 11, data integrity, audit trails, CSV/validation documentation, SOP adherence, multi-site pharma support, pharma domain experience, quality standards, stakeholder coordination, SLA management, and support documentation. Roles & Responsibilities • Provide day-to-day AMS support for Waters Empower application across multiple pharmaceutical manufacturing, QC, R&D, and laboratory sites. • Handle L1/L2/L3 application support activities including incident triage, troubleshooting, resolution, escalation, and user communication as per defined SLA and ITIL processes. • Support Empower administration activities such as user access management, roles/privileges, project creation, instrument/system configuration, audit trail review support, and routine application maintenance. • Coordinate with site laboratory teams, business users, infrastructure teams, network teams, database teams, vendors, and global application owners for issue resolution and operational continuity. • Support Empower client/server components, interfaces, instrument connectivity, instrument integration, acquisition nodes, sample set/sample creation, batch creation and batch Management, processing methods, chromatographic integration, reports, and data review workflows as applicable to site operations. • Perform root cause analysis for recurring incidents, identify preventive actions, and drive problem management to improve system stability and reduce ticket volume. • Execute and support change management activities including impact assessment, change documentation, testing coordination, deployment support, and post-implementation validation in a GxP environment. • Ensure compliance with GxP, 21 CFR Part 11, data integrity, audit trail, access control, and computer system validation requirements while supporting Empower application operations. — Email: monicacet25@gmail.com Related