Principal Associate QA - Labeling and Packaging

Eli Lilly and Company; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical/dental/vision benefits

Paid time off

Job summary

Lilly is seeking a Labeling and Packaging Quality Assurance Associate to provide quality oversight for labeling, packaging, ultra-low temperature storage, and distribution at the LP2 Advanced Therapies site in Indiana. You will partner with Manufacturing, Engineering, Regulatory Affairs, and external partners to ensure cGMP compliance and support a rapid start-up of new capabilities.

Day-to-day on-floor quality oversight, protocol development, and real-time issue resolution will be essential as

Qualifications

• Bachelor’s degree in a scientific, engineering, or other technical discipline.
• 2+ years of GMP pharmaceutical, biologics, or medical device operations, including quality assurance, manufacturing, packaging, or validation.
• Authorized to work in the United States on a full-time basis; visa sponsorship is not provided.

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 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.
• Initiate and investigate deviations, change controls, and CAPAs associated with labeling, packaging, storage, and distribution, maintaining inspection readiness as a SME.

Skills

Quality assurance

GMP experience

Labeling & packaging

On-floor operations

Risk assessment

Education

Bachelor’s degree in a scientific, engineering, or other technical discipline

Tools

Veeva Vault

Kneat

MES/electronic batch records

LIMS

Job description

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.

Job Position Overview

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.

Responsibilities

• 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.

Basic Qualifications

• 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.

Additional Skills/ Preferences

• 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 temperature mapping studies.
• Proficient in electronic quality and manufacturing systems, including Veeva Vault, Kneat, MES/electronic batch records, and LIMS.
• Proven ability to make risk-based quality decisions in real time and to escalation issues clearly under schedule pressure.

Additional Information

• Travel Percentage (%): Up to 15%
• Shift Information: Day shift, with off-shift and weekend support required during packaging campaigns, validation runs, and start-up activities. The position is on-site and requires regular presence on the manufacturing floor and in cold-chain warehouse areas.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $171,600. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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