Quality Specialist III, GxP Conformity & Continuous Improvement

Role: QA Specialist III supporting quality events, investigations, deviations, CAPAs, and continuous improvement within Arrowhead's eQMS (Veeva). Responsibilities: review, track, and approve quality events; conduct root cause analyses; assess corrective and preventive actions; support quality review boards; prepare data and trend analyses; ensure compliance with regulations and internal procedures; assist with audits and inspections; and participate in procedural documentation. Requirements: 6+ years in regulated environments, with a focus on quality assurance or auditing; strong knowledge of GMP regulations, ICH/FDA guidance; proficiency in MS Word, Excel, and Smartsheet. Preferred: Bachelor's degree; experience with electronic QMS; familiarity with drug-device combination products per 21 CFR Part 3 and medical device QSR 21 CFR Part 820/ISO 13485. High-Value: role within a biopharmaceutical company supporting quality assurance for RNAi therapeutics; emphasis on regulated environment, GxP compliance, and audit readiness. Work setup: not specified, likely office-based, in Wisconsin.