IT Support Analyst Waters NuGenesis

Job Details

• Job Title: IT Support Analyst – Waters NuGenesis
• Location: Boston, MA
• Duration: 6 months
• GBaMS ReqID: 10900441

Core Skills

• Waters NuGenesis Application Support
• NuGenesis SDMS
• NuGenesis LMS
• NuGenesis ELN
• Laboratory Informatics Support
• L1/L2/L3 AMS Support
• Incident Management
• Change Management
• Problem Management
• ITIL Processes
• User Access Management
• Roles and Privileges
• Electronic Signatures
• Audit Trails
• Scientific Data Capture
• Data Archival and Retrieval
• Metadata / Indexing
• File Capture Templates
• Print Capture
• Instrument Data Repository
• Laboratory Workflows
• Sample / Result Management
• Report Templates
• Stability Workflows
• Empower / LIMS / ERP Integration Awareness
• GxP / GMP / GLP
• 21 CFR Part 11
• EU Annex 11
• ALCOA+ Data Integrity
• CSV / Validation Documentation
• SOP Adherence
• Multi-Site Pharma Support
• Stakeholder Coordination
• SLA Management
• Service Reporting
• Support Documentation

Roles & Responsibilities

• Provide day-to-day AMS support for Waters NuGenesis applications across multiple:
  • Pharmaceutical manufacturing sites
  • QC sites
  • R&D sites
  • Laboratory sites
• Provide L1/L2/L3 application support, including:
  • Incident triage
  • Troubleshooting
  • Resolution
  • Escalation
  • User communication
• Follow defined SLA and ITIL processes.
• Support administration of:
  • NuGenesis SDMS
  • NuGenesis LMS
  • NuGenesis ELN
• Manage and support:
  • User access
  • Roles and privileges
  • Electronic signature setup
  • Audit trail support
  • Workflow configuration
  • Routine application maintenance
• Support scientific data processes, including:
  • Data capture
  • Data archival
  • Data retrieval
  • Metadata indexing
  • Print capture
  • File capture templates
  • Data retention
  • Laboratory data lifecycle management
• Coordinate with:
  • Site laboratory teams
  • Business users
  • Infrastructure teams
  • Database teams
  • Network teams
  • Vendors
  • Global application owners
• Support NuGenesis integrations and interfaces with:
  • Laboratory instruments
  • Empower CDS
  • ERP systems
  • Microsoft Office
  • File servers
  • Other enterprise systems
• Perform root cause analysis for recurring incidents.
• Identify preventive actions and drive problem management activities.
• Improve system stability and reduce ticket volume.
• Execute and support change management activities, including:
  • Impact assessments
  • Change documentation
  • Testing coordination
  • Deployment support
  • Post-implementation validation
• Ensure compliance with:
  • GxP
  • GMP
  • GLP
  • 21 CFR Part 11
  • EU Annex 11
  • ALCOA+ data integrity principles
  • Audit trail requirements
  • Access control requirements
  • Electronic records and signatures
  • Computer System Validation (CSV)
• Support:
  • Periodic reviews
  • Access recertification
  • System health checks
  • SOP adherence
  • Deviation/CAPA activities
  • Audit readiness
• Assist with NuGenesis:
  • Upgrades
  • Patches
  • Hotfixes
  • Configuration changes
  • Validation testing
  • Regression testing
  • Documentation updates
• Support global and regional NuGenesis sites.
• Create and maintain:
  • Knowledge articles
  • SOPs
  • Troubleshooting guides
  • Runbooks
  • Configuration records
  • Test evidence
  • Operational handover documents
• Monitor:
  • Application availability
  • Ticket trends
  • SLA performance
  • Recurring issues
  • User pain points
  • Service improvement opportunities
• Identify process improvement opportunities across:
  • Incident handling
  • Ticket triage
  • Recurring issue management
  • Knowledge management
  • Access request handling
  • Multi-site support operations
• Explore and propose Automation and Generative AI opportunities for:
  • Ticket summarization
  • Knowledge article creation
  • SOP/runbook drafting
  • Trend analysis
  • Root cause insights
  • Self-service enablement
  • Faster incident resolution
• Ensure AI-based support activities comply with:
  • Data privacy requirements
  • Regulatory requirements
  • Validation requirements
• Participate in:
  • Daily/weekly service reviews
  • Status reporting
  • Incident bridges
  • Major incident support
  • Stakeholder communications
• Support onboarding of new sites, including:
  • Transition activities
  • Hypercare support
  • Knowledge transfer
  • Standardization of NuGenesis support processes
• Work in shift-based or extended-hours support models as required.
• Ensure timely response to critical laboratory system issues supporting global pharmaceutical operations.