Quality Assurance Assistant — Onsite (18-Month Contract)

Joulé

Indianapolis (IN)

On-site

USD 34,000 - 39,000

Part time

6 hours ago

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Job summary

System One is seeking a Quality Assurance Assistant in Indianapolis, IN for an 18-month onsite contract. Responsibilities include supporting TrackWise audits, document control, regulatory inspection readiness, and data management. Requires degree and pharmaceutical experience.

Role offers onsite hours M-F 8am-5pm with a $25.50/hr compensation and potential extension or conversion to permanent.

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.