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
ā¢ Provide day-to-day AMS support for Waters Empower application across multiple pharmaceutical manufacturing, QC, R&D, and laboratory sites.
ā¢ Handle L1/L2/L3 application support activities including incident triage, troubleshooting, resolution, escalation, and user communication as per defined SLA and ITIL processes.
ā¢ Support Empower administration activities such as user access management, roles/privileges, project creation, instrument/system configuration, audit trail review support, and routine application maintenance.
ā¢ Coordinate with site laboratory teams, business users, infrastructure teams, network teams, database teams, vendors, and global application owners for issue resolution and operational continuity.
ā¢ 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.
ā¢ Perform root cause analysis for recurring incidents, identify preventive actions, and drive problem management to improve system stability and reduce ticket volume.
ā¢ Execute and support change management activities including impact assessment, change documentation, testing coordination, deployment support, and post-implementation validation in a GxP environment.
ā¢ Ensure compliance with GxP, 21 CFR Part 11, data integrity, audit trail, access control, and computer system validation requirements while supporting Empower application operations.
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