Lead QA: Labeling & Packaging for Start-Up Drugs

BioSpace; Lebanon (IN); Vor Ort; USD 66.000 - 172.000; Vollzeit

Benefits dieser Stelle

Travel up to 15%

On-site role

Comprehensive benefits

Zusammenfassung

Lilly in Indianapolis, Indiana, 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. This role supports the start-up of labeling and packaging capability for new drug products and provides real-time quality support on the manufacturing floor during operations.

You will partner with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and

Qualifikationen

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

Aufgaben

• Lead QA support for startup of labeling and packaging operations, including process mapping and first GMP execution.
• Provide on-the-floor QA oversight: line clearance, label reconciliation, in-process checks, batch record review.
• Support validation for labeling/packaging, including protocol development, execution, and reporting for IQ/OQ/PQ and PPQ.
• Provide QA support for storage and distribution, ultra-low temp handling, cold-chain, and post-distribution activities.
• Initiate and investigate deviations, change controls, CAPAs, and maintain inspection readiness.

Kenntnisse

Quality assurance

GMP experience

Regulatory compliance

Ausbildung

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

Tools

Veeva Vault

Kneat

MES/eBR

LIMS

Jobbeschreibung

Lilly in Indianapolis, Indiana, 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. This role supports the start-up of labeling and packaging capability for new drug products and provides real-time quality support on the manufacturing floor during operations.

You will partner with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and