Arrowhead Pharmaceuticals

Specialist III, Quality Assurance

Verona, Wisconsin, United States · Mid

Sponsorship not specified$85k-$95kDetected 14 days ago

ComplianceERPGMPFDA RegulatoryResearchAnimal StudiesCommunicationCollaborationMicrosoft Office

About the role

The purpose of the Specialist III, Quality Assurance position is to provide Quality Assurance support for Arrowhead Pharmaceuticals' raw materials program.
As a member of the Supplier Quality team, this role supports raw material supplier qualification, material risk assessment, specification development, and change control activities to ensure compliance with GMP and applicable regulatory requirements.
The position also assists with the collection, analysis, and generation of supplier performance metrics to support ongoing monitoring and continuous improvement.

Perform risk assessments for raw materials (e.g., impact to product quality, patient safety, and regulatory compliance).
Support maintenance of the ASL by providing and entering qualification information into the eQMS
Collaborate with raw material suppliers to resolve quality issues, documentation discrepancies, and non-conformances per internal procedures.
Initiate and manage change controls related to raw materials
Manage Supplier Corrective Action Requests (SCARs) per internal procedures and applicable quality agreements.
Support deviation investigations, CAPAs, and root cause analyses involving material issues.
Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
Assist with the preparation, update, review, and routing of Arrowhead procedural documents.

Prior experience with use of an Electronic Document Management System (EDMS) in a regulated environment.
Prior experience with use of an Enterprise Resource Planning (ERP) software in a regulated environment.
Working knowledge of ICH Q3, Q8, Q9, Q10, and Q11.
Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office applications, and SmartSheet.
Ability to consistently communicate with external parties in a professional manner.
Ability to follow company procedures, work instructions, and policies.
Ability to work independently with minimal supervision as well as managing priorities within a face-paced environment.
Candidates must have current, valid authorization to work in the country where this role is located.

BS/BA in Chemistry, Biology, Biochemistry, or related scientific field is preferred.

This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.