Sr. TrackWise Consultant
On-siteSan Jose, California, United States
Job Summary
Analyze, configure, modify, and implement IT Business Systems by working with process owners to identify continuous improvement opportunities. Develop detailed specifications, process flows, and functional designs for TrackWise applications, including Web Services and Crystal Reports. Manage project lifecycles, conduct user testing, and train users on new configurations while maintaining system integrity and compliance with regulatory standards like 21 CFR Part 11. Collaborate with onsite and offshore teams to ensure high-quality solution releases and contribute to knowledge management and mentoring initiatives. Requires 8+ years of TrackWise experience and familiarity with SAP integration.
Required Qualifications
- Minimum 8 years of TrackWise System Analysis experience
- Experience in Medical Device manufacturing industry and systems regulations (21 CFR Part 11, GxP, GAMP, etc.)
- Knowledge and good understanding of CAPA and Complaints processes
- Experience on TrackWise Quality View
- Ability to work on multiple projects concurrently
- Ability to work with minimum supervision or guidance
- Familiarity with Software Development Lifecycle (SDLC) processes
- Good verbal and written communication skills
Desired Qualifications
- Experience working with business end users, gathering requirements and building detailed functional design specifications
- Exposure to integration with SAP systems
- TrackWise Configuration
- TrackWise Web Service Development
- TrackWise Crystal Reports Development
- Strong knowledge and experience in Java programming
- Create workflows, Business rules, TWC automation, Notifications and Migrate updates
- Create TrackWise WebServices (Search/Populate/Transfer) using OWS/IWS
- Create and Implement Crystal Reports
- Perform business requirements gathering, requirements analysis, business system design, installation, configuration, user testing and validation support of TrackWise based applications
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