Onsite Quality Control Assistant: Audit & Documentation

System One; Indianapolis (IN); On-site; USD 30,000 - 34,000; Full time

Job summary

System One is seeking a Quality Control Assistant - CC in Indianapolis, IN for an 18-month contract. Onsite role, 8:00–5:00, Monday through Friday, supporting TrackWise audits, data entry, and document control activities to maintain inspection readiness.

The ideal candidate has a Bachelor's degree or equivalent experience, hands-on TrackWise Audit/Inspection experience, and strong MS Word/Excel/PowerPoint and SharePoint skills.

Qualifications

• Bachelor's degree or equivalent experience.
• 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.

Responsibilities

• Support Auditable Unit (AU) Coordinator activities and TrackWise naming conventions.
• Process MyAccess requests and roster reviews for TrackWise Audit/Inspection systems.
• Prepare draft audit summaries and GQAAC audit reports for review/issuance by client staff.
• Support regulatory inspection readiness and prep activities.
• Provide data entry, database updates, and SharePoint/Tableau access support.
• Assist with GQAAC compliance activities: training, CAPA, deviations, changes, self-inspections.
• Serve as QualityDocs Document Controller for select GQAAC Operations Documents.
• Collaborate with auditors, management, and customers to resolve questions.

Education

Bachelor's degree or equivalent experience

Tools

TrackWise Audit/Inspection Module

Veeva Vault

MS Word

MS Excel

PowerPoint

SharePoint

Job description

System One is seeking a Quality Control Assistant - CC in Indianapolis, IN for an 18-month contract. Onsite role, 8:00–5:00, Monday through Friday, supporting TrackWise audits, data entry, and document control activities to maintain inspection readiness.

The ideal candidate has a Bachelor's degree or equivalent experience, hands-on TrackWise Audit/Inspection experience, and strong MS Word/Excel/PowerPoint and SharePoint skills.