Specialist III, Quality Assurance (Raw Material Qualification)

The purpose of this position is to provide Quality Assurance support for Arrowhead Pharmaceuticals’ raw materials program, supporting supplier qualification, material risk assessment, specification development, and change control to ensure compliance with GMP and applicable regulatory requirements.

Responsibilities:
- Draft, edit, review, and approve raw material specifications; review qualification protocols/reports; ensure periodic requalification cycles
- Perform risk assessments for raw materials (product quality, patient safety, regulatory compliance)
- Advise Supplier Quality Audits team with supplier qualification and requalification
- Maintain ASL by providing and entering qualification information into eQMS
- Collaborate with suppliers to resolve quality issues, documentation discrepancies, and non-conformances
- Review Supplier Change Notifications and assess impact on product quality
- Initiate and manage raw-material change controls
- Manage Supplier Corrective Action Requests (SCARs)
- Support deviation investigations, CAPAs, and root cause analyses for material issues
- Provide quality oversight during material onboarding and lifecycle management
- Request/review qualification documentation (e.g., production records, CoA/CoC, BSE/TSE statements)
- Scan/upload executed documents to EDMS and route for verification/approval
- Assist with preparation/update/review/routing of procedural documents
- Track and trend raw-material quality metrics

Requirements:
- BS/BA in Chemistry, Biology, Biochemistry, or related field (preferred)
- 5+ years QA experience in GMP-regulated biotech/pharma, emphasizing raw material release/Supplier Quality/material qualification
- Working knowledge of 21 CFR Parts 210/211, ICH Q7, and global regulatory expectations (e.g., FDA, EMA, Health Canada)

Preferred:
- EDMS and ERP experience in regulated environments
- ICH Q3, Q8, Q9, Q10, Q11 knowledge
- Adobe Acrobat, Microsoft Office, SmartSheet
- Strong interpersonal/communication; ability to follow procedures and work independently

Benefits/Pay:
- Wisconsin pay range: $85,000 USD - $95,000 USD

Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.