Quality Assurance Specialist II - External Quality

Role: Provide quality assurance support for programs involving contract development, manufacturing, and testing at Arrowhead Pharmaceuticals. Responsibilities: review and approve vendor documentation (batch records, CoA, reports), perform lot disposition, generate certificates of compliance, collaborate with vendors on quality issues, and support documentation processes. Requirements: BS/BA in chemistry, biology, or biochemistry; at least 3 years of QA experience in biotech or pharma manufacturing; knowledge of GMP, GCP, GLP, ICH, and FDA guidance; strong communication and organizational skills; ability to work independently in a fast-paced environment. Preferred: experience with electronic document management systems, Adobe Acrobat, Microsoft Office, and Smartsheet. High-Value: experience in biotech/pharma development and manufacturing, quality assurance, regulated documentation, and vendor management; applicable to commercial, preclinical, and clinical programs.