Quality Control Assistant (3-5 years)

Real Soft • Indianapolis, IN

1d • Onsite

About The Position

This role supports the Global Compliance Support Team Member activities, focusing on auditable unit coordination, TrackWise system management, and regulatory inspection readiness. The position involves data entry, document control, and collaboration with various stakeholders to ensure compliance and efficient operations within the pharmaceutical industry.

Requirements

• 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
• Eligible for engagement under Lilly's contingent worker/staffing agency program

Nice To Haves

• 3-5 years of 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 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
• Collaborate with auditors, management, and customers to resolve questions

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree