Quality & Compliance Documentation Specialist

Globalchannelmanagement; Indianapolis (IN); On-site; USD 42,000 - 60,000; Full time

Job summary

Globalchannelmanagement is seeking a Quality Control Assistant in Indianapolis to support regulatory inspections and document control activities. The role requires experience in pharmaceutical QA, familiarity with TrackWise, Veeva Vault, and MS Office tools.

You will collaborate with auditors and managers to keep inspection readiness on track and ensure accurate data handling. Responsibilities include processing access requests, drafting audit summaries, maintaining documents, and supporting

Qualifications

• 3+ years of pharmaceutical industry experience.
• Experience supporting regulatory inspections (e.g., FDA).
• Experience with TrackWise Audit/Inspection Module.
• Document control experience in Veeva Vault.

Responsibilities

• Process MyAccess requests and roster reviews for TrackWise Audit/Inspection systems.
• Prepare draft audit summaries and GQAAC audit reports for review.
• Support regulatory inspection readiness and prep activities.
• Provide data entry, database updates, and SharePoint/Tableau access support.
• Serve as Quality Docs Document Controller for select GQAAC Operations Documents.
• Collaborate with auditors, management, and customers to resolve questions.

Skills

Regulatory inspections

Collaboration

Tools

TrackWise Audit/Inspection Module

MS Word

MS Excel

MS PowerPoint

SharePoint

Veeva Vault

Job description

Globalchannelmanagement is seeking a Quality Control Assistant in Indianapolis to support regulatory inspections and document control activities. The role requires experience in pharmaceutical QA, familiarity with TrackWise, Veeva Vault, and MS Office tools.

You will collaborate with auditors and managers to keep inspection readiness on track and ensure accurate data handling. Responsibilities include processing access requests, drafting audit summaries, maintaining documents, and supporting