Trackwise Analyst

TechDigital Group; Indianapolis (IN); On-site; USD 75,000 - 95,000; Full time

Job summary

TechDigital Group seeks a Business Analyst with strong TrackWise expertise to enhance Quality Management System processes in a regulated Life Sciences environment. Responsibilities include requirement analysis, stakeholder coordination, and ensuring the successful delivery of TrackWise-based solutions.

The ideal candidate will have hands-on experience with TrackWise, an understanding of quality processes in Pharma, and experience in requirement gathering and documentation. Familiarity with Agile methodologies is also beneficial.

Qualifications

• 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.

Responsibilities

• Gather, analyze, and document business and functional requirements.
• Act as a bridge between business stakeholders and technical teams.
• Provide functional support for TrackWise modules.
• Conduct process mapping 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.

Skills

TrackWise expertise

Quality processes knowledge

Requirement gathering

Stakeholder management

Process mapping tools knowledge

Agile methodologies familiarity

Tools

JIRA

Confluence

MS Office Suite

Job description

Trackwise Functional, Business Analysis

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