TrackWise QMS Analyst - Bridge to Quality in Life Sciences
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-10-24
Listing for:
TechDigital Group
Full Time
position Listed on 2026-10-24
Job specializations:
-
Business
Business Systems & Technology Analysis, Data Analyst
Job Description & How to Apply Below
Trackwise Functional, Business Analysis
Role
Description:
Business Analyst with strong Track Wise functional expertise to support and enhance Quality Management System (QMS) processes in a regulated Life Sciences environment. The role involves requirement analysis, stakeholder coordination, and ensuring successful delivery of Track Wise-based solutions.
Key Responsibilities:
- Gather, analyze, and document business and functional requirements (BRD/FRD/User Stories)
- Act as a bridge between business stakeholders and technical teams
- Provide functional support for Track Wise modules (Deviation, CAPA, Change Control, Audit, Complaints)
- Conduct process mapping (As-Is / To-Be) and identify improvement opportunities
- Support UAT planning, execution, and defect management
- Ensure compliance with GxP and regulatory standards
- Collaborate with cross-functional teams for smooth delivery and issue resolution
Required Skills
- Strong hands-on experience with Track Wise (QMS platform)
- Solid understanding of Quality processes in Pharma / Life Sciences
- Experience in requirement gathering, documentation, and stakeholder management
- Knowledge of process mapping tools (Visio/BPMN)
- Familiarity with Agile/Scrum methodologies
Tools: JIRA, Confluence, MS Office Suite
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