Quality Systems Specialist

Full-time Business Operations Specialists

Job Title: Quality Systems Specialist

Job Description

The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, executing and maintaining processes managed through the MasterControl electronic Quality Management System (eQMS). This role involves building and managing a supplier and vendor quality program, including qualification and auditing of suppliers, with occasional domestic and international travel required. The specialist is responsible for GMP training programs, validation and qualification document review, deviations, investigations, CAPAs, and change controls. Collaboration cross-functionally to ensure compliance with internal procedures and global regulatory requirements is essential.

Responsibilities

Build and manage a supplier and vendor quality program, including qualification and auditing of suppliers.

Execute and maintain processes managed through ...