Labeling & Packaging QA Associate — Cold-Chain Startups

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

Company bonus

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Job summary

Lilly is seeking a Labeling and Packaging Quality Assurance Associate to support the LP2 Advanced Therapies site in Indianapolis, IN. You will oversee labeling, packaging, ultra-low temperature storage, and distribution operations, helping start up new capabilities and ensuring real-time quality on the manufacturing floor.

You will collaborate with Manufacturing, Engineering, Regulatory Affairs, and Supply Chain, perform validation activities for multiple ultra-low temperature products, and

Qualifications

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

Responsibilities

• Lead QA support for startup of labeling and packaging operations for new drug products.
• Provide on-the-floor quality oversight including line clearance and real-time issue resolution.
• Support validation of labeling/packaging for multiple ultra-low temperature products.
• Ensure storage, cold-chain, and distribution quality with end-to-end QA support.
• Initiate investigations into deviations, change controls, and CAPAs; maintain inspection readiness.

Tools

Veeva Vault

Kneat

MES/electronic batch records

LIMS

Job description

Lilly is seeking a Labeling and Packaging Quality Assurance Associate to support the LP2 Advanced Therapies site in Indianapolis, IN. You will oversee labeling, packaging, ultra-low temperature storage, and distribution operations, helping start up new capabilities and ensuring real-time quality on the manufacturing floor.

You will collaborate with Manufacturing, Engineering, Regulatory Affairs, and Supply Chain, perform validation activities for multiple ultra-low temperature products, and