Labeling & Packaging QA Lead – Start-Up & Cold-Chain Impact

712 Lly Lebanon Adv Therapies; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being benefits

Job summary

Lilly in Indianapolis, IN, seeks a Labeling and Packaging Quality Assurance Associate to oversee labeling, packaging, ultra-low temperature storage, and distribution operations at the LP2 Advanced Therapies site. You will support start-up of labeling and packaging capabilities for new products and provide on-the-floor quality oversight during manufacturing.

Responsibilities include process mapping, batch record review, line clearance, and validation protocol execution, with collaboration across

Qualifications

• Bachelor’s degree in a scientific, engineering, or technical discipline.
• 2+ years of GMP pharmaceutical, biologics, or medical device operations experience.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Lead QA support for start-up labeling and packaging for new products, including batch record development and proof approval.
• Provide on-the-floor QA oversight during labeling and packaging operations and real-time issue resolution.
• Support validation of labeling/packaging for ultra-low temperature products, including protocol development and PPQ activities.
• Provide QA support for storage and distribution, including cryogenic handling and cold-chain reviews.
• Initiate and investigate deviations, change controls, and CAPAs; maintain inspection readiness.

Skills

Quality Assurance

GMP Knowledge

Problem Solving

Cross-functional Collaboration

Education

Bachelor’s degree in science/engineering

Tools

Veeva Vault

Kneat

MES/eBRS

LIMS

Job description

Lilly in Indianapolis, IN, seeks a Labeling and Packaging Quality Assurance Associate to oversee labeling, packaging, ultra-low temperature storage, and distribution operations at the LP2 Advanced Therapies site. You will support start-up of labeling and packaging capabilities for new products and provide on-the-floor quality oversight during manufacturing.

Responsibilities include process mapping, batch record review, line clearance, and validation protocol execution, with collaboration across