Specialist III, Quality Assurance Raw Material Qualification

The Position

The purpose of this 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.

Responsibilities

• 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
• Perform risk assessments for raw materials (e.g., impact to product quality, patient safety, and regulatory compliance)
• Advise Supplier Quality Audits team with supplier qualification and requalification as needed
• Support maintenance of the ASL by providing and entering qualification information into the eQM
• Collaborate with raw material suppliers to resolve quality issues, documentation discrepancies, and non-conformances per internal procedures
• Review Supplier Change Notifications and assess impact on product quality
• 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
• Provide quality oversight during material onboarding and lifecycle management
• Request and review supporting documentation for raw material qualifications from suppliers including, but not limited to, production records, certificates of analysis (CoA), certificates of conformance (CoC), BSE/TSE statements, etc
• 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
• Track and trend raw material-related quality metrics
• Assist with other QA duties as needed

Requirements

• BS/BA in Chemistry, Biology, Biochemistry, or related scientific field is preferred
• Minimum of 5+ years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment, with an emphasis on raw material release, Supplier Quality, and/or material qualification activities
• Working knowledge of 21 CFR Parts 210/211, ICH Q7, and applicable global regulatory expectations (e.g., FDA, EMA, Health Canada), along with familiarity with relevant regulatory guidance documents
• Preferred:
• 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
• Excellent interpersonal, verbal, and written communication skills
• Ability to consistently communicate with external parties in a professional manner
• Ability to follow company procedures, work instructions, and policies
• Excellent attention to detail and organizational skills
• Ability to work independently with minimal supervision as well as managing priorities within a face-paced environment