Job Description

Manufacturing Support Specialist to support manufacturing operations by managing controlled documentation, coordinating Engineering Change Orders (ECOs), and assisting with continuous improvement initiatives in a highly regulated FDA and ISO environment.

Key Responsibilities

Support manufacturing areas with the implementation of document changes through Engineering Change Order (ECO) systems.
Ensure documentation updates related to Capital Projects, Validation activities, Quality Notifications, and CAPAs are completed on time.
Create, format, revise, and maintain SOPs, manufacturing batch records, and other GMP-required documentation.
Assist in manufacturing data collection, reporting, and performance metrics tracking.
Participate in Continuous Improvement (CI) and Lean Manufacturing