Role Description

Position Summary:

Owns day-to-day execution and coordination of the stability program to ensure compliant study setup, sample management, testing coordination, data review support, and on-time reporting. Partners cross-functionally to maintain high data integrity, inspection readiness, and continuous improvement. Acts as site laboratory management system (SAP/zLIMS) subject matter expert. Maintains compliance through creation and maintenance of biological product specifications and COA templates. The successful candidate must be a self-starter and have the ability to prioritize work based on the needs of Production, Quality Assurance, Quality Control, Regulatory, Global Manufacturing Technologies and Supply Chain.

Position Responsibilities:

Stability: