Quality Specialist II, Raw Material Qualification

Quality Specialist II, Raw Material Qualification

Quality Specialist II, Raw Material Qualification

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein.

Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics.

Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

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 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.

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.

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…