Quality Systems Specialist Overview
The Quality Systems Specialist is responsible for managing and maintaining Quality Management System (QMS) processes to ensure compliance with cGMP, GxP, ICH, ISO, and internal quality standards within a regulated manufacturing environment.
This role plays a key part in supporting core QMS functions—including document control, training administration, audits, and compliance activities—while partnering cross-functionally to resolve quality issues, support continuous improvement initiatives, and enhance overall system effectiveness.
Key Responsibilities

+ Manage and maintain the Quality Management System (QMS) to ensure regulatory and internal compliance.

+ Coordinate quality system processes such as document control, training administration, audit support, and compliance tracking.

+ Author, revise, review, route, and maintain controlled documents (SOPs, work instructions, and forms).

+ Ensure document accur...