Opportunity Description
Job Title: Quality Systems Specialist - Auditing and Vendor ManagementJob Description
The Quality Systems QA 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 th...
The Quality Systems QA 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 th...
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