QA Lead, Labeling & Packaging Start-Up (Ultra-Cold)

Regulatory Jobs; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Health insurance

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly in Indianapolis, Indiana, is seeking a Labeling and Packaging Quality Assurance Associate to provide quality oversight for labeling, packaging, and cold-chain operations. This on-site role supports start-up activities for new products, real-time QA on the floor, and validation of labeling and packaging for ultra-low temperature products.

The ideal candidate has a BS in a scientific or technical field, 2+ years of GMP pharma/biotech experience, and is authorized to work in the United States

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; no visa sponsorship.

Responsibilities

• Lead QA support for startup labeling and packaging operations, including process mapping and batch record development.
• On-the-floor QA oversight during operations, including line clearance and in-process checks.
• Support validation of labeling/packaging for ultra-low temperature products.
• Quality support for storage and distribution, cold-chain and release-to-ship processes.
• Initiate deviations, change controls, CAPAs, and maintain inspection readiness.

Skills

Quality assurance

GMP knowledge

Cross-functional collaboration

Documentation

Education

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

Tools

Veeva Vault

Kneat

MES/electronic batch records

LIMS

Job description

Lilly in Indianapolis, Indiana, is seeking a Labeling and Packaging Quality Assurance Associate to provide quality oversight for labeling, packaging, and cold-chain operations. This on-site role supports start-up activities for new products, real-time QA on the floor, and validation of labeling and packaging for ultra-low temperature products.

The ideal candidate has a BS in a scientific or technical field, 2+ years of GMP pharma/biotech experience, and is authorized to work in the United States