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Quality Systems Specialist - CAPAs And Deviations
Actalent
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Waunakee, United States
Location
Waunakee
Posted
June 06, 2026
Commute
Local Area
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Job Description
Job Title: Quality Systems Specialist โ CAPAs and DeviationsJob Description
The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, with a primary focus on managing corrective and preventive actions (CAPAs) and deviations. This role executes and maintains key quality processes, including GMP training programs, validation and qualification document review, investigations, change controls, and CAPAs. The specialist collaborates crossโfunctionally to ensure adherence to quality system procedures, supports continuous improvement initiatives, and helps maintain regulatory compliance and product quality through effective governance of quality systems.
Responsibilities
+ Oversee the CAPA system on a daily basis, including tracking actions, monitoring progress, and driving timely closure of CAPAs.
+ Initiate, review, and manage deviations, ensuring accurate documentation, appropriate impact assessment,...
The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, with a primary focus on managing corrective and preventive actions (CAPAs) and deviations. This role executes and maintains key quality processes, including GMP training programs, validation and qualification document review, investigations, change controls, and CAPAs. The specialist collaborates crossโfunctionally to ensure adherence to quality system procedures, supports continuous improvement initiatives, and helps maintain regulatory compliance and product quality through effective governance of quality systems.
Responsibilities
+ Oversee the CAPA system on a daily basis, including tracking actions, monitoring progress, and driving timely closure of CAPAs.
+ Initiate, review, and manage deviations, ensuring accurate documentation, appropriate impact assessment,...