Role Description: Business Analyst with strong TrackWise 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 TrackWise-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 TrackWise 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 TrackWise (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
Numbers & Facts
Location
Indianapolis, IN
Industry
Other/Not Classified
Company Size
100 to 499 employees
Skills
Acceptance Testingunmatched
Agile Programming Methodologiesunmatched
Analysis Skillsunmatched
Atlassian JIRAunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Bug Tracking/Defect Managementunmatched
Business Analysisunmatched
Change Controlunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Documentationunmatched
Environmental Sciencesunmatched
Functional Analysisunmatched
Functional Requirements Document (FRD)unmatched
GxPunmatched
Maintain Complianceunmatched
Microsoft Officeunmatched
Microsoft Visiounmatched
Problem Solving Skillsunmatched
Quality Managementunmatched
Regulatory Complianceunmatched
Requirements Managementunmatched
Scrum Project Management and Software Developmentunmatched
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