Quality Control Assistant: TrackWise Audit & Docs

Fives DyAG Corp.; Indianapolis (IN); On-site; USD 33,000 - 36,000; Part time

Benefits offered by this job

Health insurance

Health savings account

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Retirement plan

Job summary

Fives DyAG Corp. in Indianapolis, IN seeks a Quality Control Assistant for an 18-month contract. Pay range is $24.00–$25.54 per hour. The role supports Auditable Unit activities, TrackWise naming conventions, and regulatory inspection readiness.

The candidate will handle MyAccess requests, roster reviews for TrackWise systems, draft audit summaries, and assist with GQAAC compliance, data entry, and SharePoint/Tableau access. Collaboration with Lilly staff is required.

Qualifications

• 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 convention.
• Process MyAccess requests and roster reviews for TrackWise Audit/Inspection systems.
• Prepare draft audit summaries and GQAAC audit reports for review/issuance by Lilly 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.

Skills

Regulatory inspections experience

Pharmaceutical industry experience

Documentation management

Education

Bachelor's degree or equivalent experience

Tools

TrackWise Audit/Inspection Module

MS Word

MS Excel

PowerPoint

SharePoint

Veeva Vault document control

Job description

Fives DyAG Corp. in Indianapolis, IN seeks a Quality Control Assistant for an 18-month contract. Pay range is $24.00–$25.54 per hour. The role supports Auditable Unit activities, TrackWise naming conventions, and regulatory inspection readiness.

The candidate will handle MyAccess requests, roster reviews for TrackWise systems, draft audit summaries, and assist with GQAAC compliance, data entry, and SharePoint/Tableau access. Collaboration with Lilly staff is required.