Specialist III, Quality Assurance
Arrowhead Pharmaceuticals , Verona, Wisconsin +1
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.
This role requires regular interaction with internal cross-functional stakeholders as well as external organizations to support pre-clinical, clinical, and commercial manufacturing programs
What you will do
- Assist with raw material lifecycle management including, but not limited to, drafting, editing, reviewing, and approving raw material specifications, reviewing raw material qualification protocols and reports, and ensuring compliance with periodic requalification cycles, in collaboration with internal functional teams