Arrowhead Pharmaceuticals · 6 hours ago
Quality Specialist II, Raw Material Qualification
Verona, WI
Full-time
Onsite
Mid Level
$70K/yr - $85K/yr
3+ years expArrowhead Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Quality Specialist II role involves providing Quality Assurance support for raw materials, reviewing supplier documentation, and ensuring GMP compliance while collaborating with internal and external stakeholders.
BiotechnologyHealth CareNanotechnologyPharmaceutical
No H1B
Responsibilities
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
Qualification
Required
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
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 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
Benefits
Competitive salaries
Excellent benefit package
Company
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals is a biotechnology company that focuses on the development of medicine to treat diseases with a genetic origin.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.45BKey Investors
Sarepta TherapeuticsSixth StreetSilence Therapeutics
2026-01-07Post Ipo Equity· $200M
2026-01-07Post Ipo Debt· $625M
2024-11-26Post Ipo Equity· $325M
Leadership Team
Christopher Anzalone
President and Chief Executive Officer
Recent News
2026-01-14
Company data provided by crunchbase