Principal Associate QA - Labeling and Packaging

Role: Quality Assurance Associate overseeing labeling, packaging, and cold-chain distribution for ultra-low temperature biologics at Lilly's Advanced Therapies site. Responsibilities: lead start-up activities for new drug products, provide real-time quality oversight during manufacturing, support validation of labeling and packaging processes, ensure compliance with cGMP, manage deviations, change controls, CAPAs, and maintain inspection readiness. Requirements: Bachelor's in a scientific or technical discipline, 2+ years in GMP pharma/biologics/medical devices, experience in quality assurance, manufacturing, packaging, validation; authorized to work in the U.S. Additional skills: experience with pharma labeling, cell/gene therapy, serialization, validation protocols, electronic systems like Veeva, MES, LIMS; risk-based decision-making skills. High-value: biologics, cell/gene therapy, ultra-low temperature storage, validation (IQ/OQ/PQ, PPQ), GMP compliance, validation, cold-chain distribution. Work setup: on-site, with up to 15% travel, day shift with support during campaigns and start-up activities.