Quality Control Assistant

Globalchannelmanagement; Indianapolis (IN); On-site; USD 52,000 - 68,000; Full time

Job summary

Globalchannelmanagement is seeking a Quality Control Assistant in Indianapolis to support regulatory inspections and document control. The role focuses on TrackWise system activities, data management, and cross-functional collaboration with auditors and management.

The candidate will handle access requests, audit report preparation, and readiness activities for regulatory inspections, ensuring accurate documentation across SharePoint and Tableau platforms.

Qualifications

• Experience with TrackWise Audit/Inspection module.
• Proficiency in MS Word, Excel, PowerPoint, and SharePoint.
• Experience with document control in Veeva Vault.
• Experience supporting regulatory inspections (e.g., FDA) - 1+ years of pharmaceutical industry experience.

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

TrackWise Audit/Inspection

FDA regulatory inspections

Regulatory documentation

Regulatory process understanding

Tools

TrackWise Audit/Inspection Module

MS Word

Excel

PowerPoint

SharePoint

Veeva Vault

Job description

Quality Control Assistant needs 3- years' experience

MUST:

• Experience with TrackWise Audit/Inspection Module –
• Proficiency in MS Word, Excel, PowerPoint, SharePoint –
• Experience with document control in Veeva Vault –
• Experience supporting regulatory inspections (e.g., FDA) - 1+ years of pharmaceutical industry experience –

DUTIES:

• 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