Specialist III, Quality Assurance
Arrowhead Pharmaceuticals
August 17, 2026
On-site
Verona, WI
Operations
Responsibilities:
- Support raw material lifecycle management: draft/edit/review/approve raw material specifications; review qualification protocols/reports; ensure compliance with requalification cycles.
- Perform raw material risk assessments (product quality, patient safety, regulatory compliance).
- Support supplier qualification and requalification with the Supplier Quality Audits team.
- Maintain the ASL by providing/entering qualification information into the eQMS.
- Collaborate with suppliers to resolve quality issues, documentation discrepancies, and non-conformances.
- Review Supplier Change Notifications and assess impact to product quality.
- Initiate and manage raw-material change controls.
- Manage Supplier Corrective Action Requests (SCARs).
- Support deviation investigations, CAPAs, and root cause analyses involving 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 the EDMS, categorize, and route for verification/approval.
- Assist with preparation/update/review/routing of procedural documents.
- Track and trend raw-material quality metrics.
- Assist with other QA duties as needed.
Requirements:
- BS/BA in Chemistry, Biology, Biochemistry, or related field (preferred).
- 5+ years QA experience in GMP-regulated biotech/pharma, with emphasis on raw material release, Supplier Quality, and/or material qualification.
- Working knowledge of 21 CFR 210/211, ICH Q7, and global regulatory expectations (e.g., FDA/EMA/Health Canada).
Preferred:
- EDMS experience.
- ERP experience.
- ICH Q3, Q8, Q9, Q10, Q11.
- Adobe Acrobat, Microsoft Office, SmartSheet.
- Strong communication and organization; ability to work independently in a fast-paced environment.
Benefits/Application:
- Wisconsin pay range: $85,000 USD - $95,000 USD.
- Authorization to work in the country where the role is located is required.
- Support raw material lifecycle management: draft/edit/review/approve raw material specifications; review qualification protocols/reports; ensure compliance with requalification cycles.
- Perform raw material risk assessments (product quality, patient safety, regulatory compliance).
- Support supplier qualification and requalification with the Supplier Quality Audits team.
- Maintain the ASL by providing/entering qualification information into the eQMS.
- Collaborate with suppliers to resolve quality issues, documentation discrepancies, and non-conformances.
- Review Supplier Change Notifications and assess impact to product quality.
- Initiate and manage raw-material change controls.
- Manage Supplier Corrective Action Requests (SCARs).
- Support deviation investigations, CAPAs, and root cause analyses involving 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 the EDMS, categorize, and route for verification/approval.
- Assist with preparation/update/review/routing of procedural documents.
- Track and trend raw-material quality metrics.
- Assist with other QA duties as needed.
Requirements:
- BS/BA in Chemistry, Biology, Biochemistry, or related field (preferred).
- 5+ years QA experience in GMP-regulated biotech/pharma, with emphasis on raw material release, Supplier Quality, and/or material qualification.
- Working knowledge of 21 CFR 210/211, ICH Q7, and global regulatory expectations (e.g., FDA/EMA/Health Canada).
Preferred:
- EDMS experience.
- ERP experience.
- ICH Q3, Q8, Q9, Q10, Q11.
- Adobe Acrobat, Microsoft Office, SmartSheet.
- Strong communication and organization; ability to work independently in a fast-paced environment.
Benefits/Application:
- Wisconsin pay range: $85,000 USD - $95,000 USD.
- Authorization to work in the country where the role is located is required.