Quality Control Assistant - CC

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

Job Title: Quality Control Assistant - CC
Location: Indianapolis, IN
Type: 18-month Contract
Compensation: $22.00 - $25.00
Work Model: Onsite – onsite
Hours: MF 8-5

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

Requirements

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

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.