Specialist III, Quality Assurance

Role: Quality Assurance specialist supporting raw materials for Arrowhead Pharmaceuticals' biopharma manufacturing, primarily focused on ensuring GMP compliance and supplier qualification. Responsibilities: manage raw material lifecycle, conduct risk assessments, support supplier audits, oversee change controls, review qualification documentation, address quality issues, and monitor quality metrics. Requirements: BS/BA in Chemistry, Biology, Biochemistry, or related field; 5+ years in GMP biotech/pharma QA with experience in raw material release and qualification; knowledge of 21 CFR Parts 210/211, ICH Q7, and global regulatory standards. Preferred: experience with EDMS, ERP systems, and familiarity with ICH Q3, Q8, Q9, Q10, and Q11; strong communication and organizational skills, proficiency in MS Office and document management tools. High-Value: GMP-regulated environment, raw material qualification, supplier quality oversight, documentation review, and risk assessment in biopharma manufacturing. Work setup: not specified; salary range $85K-$95K.