Quality Assurance Assistant – TrackWise & Regulatory Support

System One, Inc.; Indianapolis (IN); On-site; USD 52,000 - 56,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Dental and vision

Job summary

System One is seeking a Quality Assurance Assistant in Indianapolis, IN for an onsite, 18-month contract. The role supports AU activities, TrackWise naming conventions, and regulatory inspection readiness. Proficiency in TrackWise, Veeva Vault, and MS Office is required, with 1+ year pharma experience.

The role offers a structured contract position with benefits through System One, including health coverage and 401(k) options. Strong collaboration with auditors and management is essential.

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 company 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.

Skills

Pharma industry experience

Regulatory inspections experience

Attention to detail

Education

Bachelor's degree or equivalent experience

Tools

TrackWise Audit/Inspection Module

Veeva Vault document control

MS Word

MS Excel

PowerPoint

SharePoint

Job description

Job Title: Quality Assurance Assistant
Location: Indianapolis, IN
Work Model: Onsite
Hours: M-F 8am-5pm
Compensation: $25.50/hr
Type: 18-month contract, Potential for extension or conversion to permanent
Security Clearance: Not specified

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 company 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

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.

#M-

#LI-

Ref: #558-Scientific