More jobs:
Quality Assurance Operational Support
Job in
Lebanon, Boone County, Indiana, 46052, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Quality Assurance Operational Support Representative for Lilly’s new advanced therapies manufacturing site, focusing on gene therapy modalities in Lebanon, Indiana. Objectives include ensuring GMP compliance, supporting facility startup, and maintaining quality systems for clinical and commercial supply.
Responsibilities- provide technical and quality review of documents
- oversee equipment verification
- lead investigations of deviations, change controls, and batch record reviews
- support regulatory inspections
- lead/support process initiatives
- promote a strong quality culture
- monitor GMP adherence on-site
- Bachelor’s in science, engineering, or related field
- 3+ years in pharmaceutical QA roles
- experience with GMP, regulatory standards (US, EU, Japan), and equipment validation
- knowledge of gene therapy manufacturing processes
- technical writing skills
- proficiency with systems like Veeva Vault, SAP, and automation platforms
- gene therapy modalities
- manufacturing startup
- GMP compliance
- equipment validation
- regulatory inspection support
- cross-functional team collaboration
not specified; likely on-site in Lebanon, Indiana.
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