Quality Systems Specialist - CAPAs And Deviations

Confidential
📍 Waunakee, Wisconsin, United States 💼 Full-time 🕒 Posted June 10, 2026

Job Description

Job Title: Quality Systems Specialist – CAPAs and Deviations
Job 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 cross‑functionally 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, appropria...
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    Job Details

    • Location Waunakee, Wisconsin
    • Job Type Full-time
    • Category Business Operations Specialists
    • Posted Date June 10, 2026
    • Application Deadline July 20, 2026