Location
Madison, WI, United States
Posted
July 11, 2026
Job Description
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 the MasterControl eQMS.
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 the MasterControl eQMS.