Quality Control Assistant (Biotech/Biomedical)

Job Description

Job DescriptionGlobal Compliance Support Team Member
- 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

Qualifications:
Minimum 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

Education:
Bachelor's degree or equivalent experience