Lead QA, Labeling & Packaging for Cryogenic Drugs

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

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