Quality Specialist II, Raw Material Qualification

• 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

• 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

• 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

competitive salaries and an excellent benefit package