Quality Specialist III, GxP Conformity & Continuous Improvement
Arrowhead Pharmaceuticals
August 06, 2026
Remote friendly (Madison, WI)
United States
Operations
The QA Specialist III role is responsible for supporting Quality Events, including laboratory investigations, deviations, continuous improvement initiatives, and CAPAs within Arrowhead Pharmaceutical’s eQMS (Veeva). Ensure timely, efficient, and thorough investigations for conformance events, assess the suitability and adequacy of subsequent actions, and support continued tracking/trending of quality metrics.
Responsibilities:
- Support eQMS workflows related to Quality Events.
- Review, track, and approve Quality Events within eQMS.
- Support operations with investigations, identifying root cause and determining corrective and preventive actions.
- Review adequacy of CAPAs.
- Support quality review board activities by preparing data and tracking follow-up actions.
- Identify, communicate, and escalate observed trends with internal stakeholders.
- Prepare and present data and trends to internal stakeholders.
- Interact with other departments to investigate and close QEs within eQMS.
- Write, review, and approve procedural documents.
- Participate and support audits and inspections.
- Ensure compliance with applicable regulations, international standards, and internal procedures.
- Assist with other QA duties as needed.
Requirements:
- 6 years of experience in a regulated environment (preference for QA auditing).
- Working knowledge of drug GMP regulations and ICH/FDA guidance.
- Proficient in Microsoft Word, Excel, and Smartsheet.
Preferred:
- Bachelor’s degree.
- Experience using an electronic document and/or quality management system in a regulated environment.
- Experience with quality systems for drug-device combination products (21 CFR Part 3) and medical devices QSR (21 CFR Part 820/ISO 13485).
Benefits/Pay:
- Wisconsin pay range: $78,000 USD - $98,000 USD.
- Competitive salaries and an excellent benefit package.
Application instruction:
- Candidates must have current, valid authorization to work in the country where this role is located.
Responsibilities:
- Support eQMS workflows related to Quality Events.
- Review, track, and approve Quality Events within eQMS.
- Support operations with investigations, identifying root cause and determining corrective and preventive actions.
- Review adequacy of CAPAs.
- Support quality review board activities by preparing data and tracking follow-up actions.
- Identify, communicate, and escalate observed trends with internal stakeholders.
- Prepare and present data and trends to internal stakeholders.
- Interact with other departments to investigate and close QEs within eQMS.
- Write, review, and approve procedural documents.
- Participate and support audits and inspections.
- Ensure compliance with applicable regulations, international standards, and internal procedures.
- Assist with other QA duties as needed.
Requirements:
- 6 years of experience in a regulated environment (preference for QA auditing).
- Working knowledge of drug GMP regulations and ICH/FDA guidance.
- Proficient in Microsoft Word, Excel, and Smartsheet.
Preferred:
- Bachelor’s degree.
- Experience using an electronic document and/or quality management system in a regulated environment.
- Experience with quality systems for drug-device combination products (21 CFR Part 3) and medical devices QSR (21 CFR Part 820/ISO 13485).
Benefits/Pay:
- Wisconsin pay range: $78,000 USD - $98,000 USD.
- Competitive salaries and an excellent benefit package.
Application instruction:
- Candidates must have current, valid authorization to work in the country where this role is located.