Principal Associate QA - Labeling and Packaging

Lilly • Lebanon, IN

5d • $66,000 - $171,600 • Onsite

About The Position

The Labeling and Packaging Quality Assurance Associate provides quality oversight for labeling, packaging, ultra-low temperature storage, and distribution operations at Lilly’s LP2 Advanced Therapies site. The role supports start-up of labeling and packaging capabilities for new drug products, provides real-time quality support on the manufacturing floor, and supports validation for multiple new ultra-low temperature products. It works with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and external partners to ensure operations meet cGMP requirements and regulatory commitments. The position also provides end-user support for post-distribution activities to help meet patient needs.

The position is on-site, with regular presence on the manufacturing floor and in cold-chain warehouse areas. The usual schedule is day shift, with off-shift and weekend support required during packaging campaigns, validation runs, and start-up activities. Travel may be up to 15%.

Requirements

• Bachelor’s degree in a scientific, engineering, or other technical discipline.
• At least 2 years of experience in GMP pharmaceutical, biologics, or medical device operations, including experience in quality assurance, manufacturing, packaging, or validation.
• Must be authorized to work in the United States on a full-time basis; Lilly will not support or sponsor work authorization or visas for this role.

Nice To Haves

• Previous experience in pharmaceutical labeling and packaging operations, including line clearance, label reconciliation, and serialization.
• Previous experience with cell therapy, gene therapy, vaccines, 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.
• Ability to author and execute validation protocols (IQ/OQ/PQ, EMPQ, PPQ) and temperature mapping studies.
• Proficiency with electronic quality and manufacturing systems, including Veeva Vault, Kneat, MES/electronic batch records, and LIMS.
• Ability to make risk-based quality decisions in real time and clearly escalate issues under schedule pressure.

Responsibilities

• Lead quality assurance support for 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 new ultra-low temperature drug products, including protocol development, execution, and reporting for equipment qualification and PPQ activities.
• Provide quality support for drug product storage and distribution, including ultra-low temperature and cryogenic storage, cold-chain excursion review, shipping lane and container qualification, and release-to-ship processes.
• Provide 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.
• Maintain inspection readiness of the area as a subject matter expert.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior