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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 is responsible for reviewing supplier documentation, performing disposition of incoming raw materials in accordance with applicable procedures, and supporting supplier-related quality activities to ensure GMP compliance. 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.
Job Responsibility:
Review and approve raw material supplier documentation including CoAs, CoCs, BSE/TSE statements, production records, and supporting GMP documentation in accordance with internal procedures
Review internally generated raw material testing documentation and perform lot disposition for incoming raw materials
Collaborate with raw material suppliers to resolve quality issues, documentation discrepancies, and non-conformances per internal procedures
Issue, track, and follow-up on Supplier Corrective Action Requests (SCARs) per internal procedures and applicable quality agreements
Request supporting documentation for raw material qualification from suppliers including, but not limited to, production records, certificates of analysis (CoA), certificates of conformance (CoC), BSE/TSE statements, etc.
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
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
Assist with other QA duties as needed
Requirements:
BS/BA in Chemistry, Biology, Biochemistry, or related scientific field is preferred
3 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
Nice to have:
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 programs, 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
What we offer:
competitive salaries and an excellent benefit package