Quality Assurance Specialist II - Internal Quality

Role: Quality Assurance Specialist II supporting development programs for preclinical, clinical, and commercial drug candidates at Arrowhead Pharmaceuticals, focusing on cGMP compliance and documentation review. Responsibilities: review and approve manufacturing batch records, analytical data, raw materials, and perform lot disposition and release activities; support investigations, deviations, and documentation management; ensure compliance with GMP, GCP, and GLP regulations; assist with training on GMP and data integrity. Requirements: BS/BA in chemistry, biology, biochemistry; minimum 3 years QA experience in biotech/pharma manufacturing or development; knowledge of GMP, GCP, GLP, ICH, FDA guidance; strong communication, organizational, and independent work skills. Preferred: experience with GMP quality systems (21 CFR Parts 11, 210, 211), proficiency in MS Office, prior use of electronic document management systems. High-Value: support for drug development, manufacturing, and quality systems in a regulated environment; cross-departmental interaction including manufacturing, QC, analytical development; no specific therapeutic area or modality specified. Work setup: not specified; location implied to be in Wisconsin with competitive salary range.