Principal Associate QA - Labeling and Packaging

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work - but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Labeling and Packaging Quality Assurance Associate provides quality oversight for labeling, packaging, ultra-low temperature storage, and distribution operations at the LP2 Advanced Therapies site. This position supports the start-up of labeling and packaging capability for new drug products, provides real-time quality support on the manufacturing floor during operations, and supports validation of labeling and packaging for multiple new ultra-low temperature products.

The role partners with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and external partners to ensure labeling and packaging operations meet cGMP requirements and regulatory commitments. This position also provides white-glove, end-user support for post-distribution activities to ensure patient needs are met.

• Lead quality assurance support for the start-up of labeling and packaging operations for new drug products, including process mapping, procedure and batch record development, artwork and label proof approval, and first GMP execution.
• Provide on-the-floor quality oversight during labeling and packaging operations, including line clearance, label reconciliation, in-process checks, batch record review, and real-time resolution of floor questions.
• Support validation of labeling and packaging for multiple new ultra-low temperature drug products, including protocol development, execution, and reporting for equipment qualification, and PPQ activities.
• Provide quality support for storage and distribution of drug product, including ultra-low temperature and cryogenic storage, cold-chain excursion review, shipping lane and container qualification, and release-to-ship processes. Provide white-glove, end-user support for post-distribution activities to ensure patient needs are met.
• Initiate and investigate deviations, change controls, and CAPAs associated with labeling, packaging, storage, and distribution, and maintain inspection readiness of the area as a subject matter expert.

• Bachelor’s degree in a scientific, engineering, or other technical discipline.
• 2+ years of experience in GMP pharmaceutical, biologics, or medical device operations, including experience in quality assurance, manufacturing, packaging, or validation.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

• Previous experience in pharmaceutical labeling and packaging operations, including line clearance, label reconciliation, and serialization.
• Previous experience with cell therapy, gene therapy, vaccine, or other products requiring ultra-low temperature or cryogenic handling and cold-chain distribution.
• Prior work with new product introduction, technology transfer, or start-up of a new manufacturing capability.
• Proven ability to author and execute validation protocols (IQ/OQ/PQ, EMPQ, PPQ) and…