Specialist I, Supplier Quality

Job Description

Job Description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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

This position supports Supplier Quality Assurance with activities related to supplier qualification and regulatory compliance. Responsibilities include supplier intake, supplier records management, and supplier audit support. The Supplier Qualification Specialist I will collaborate with Arrowhead business teams, the Supplier Quality team, and internal and external auditors.

Responsibilities

• Manage initial intake of new regulated suppliers from the business teams
• Conduct or assist with supplier risk assessments
• Coordinate with internal and external auditors performing supplier audits
• Maintain supplier, audit, and qualification records within Veeva
• Support Lead Auditors by tracking timelines and preparing required documentation
• Maintain supplier licenses, certifications, and related compliance documentation within Veeva
• Generate and distribute supplier metrics to QA groups and business stakeholders
• Support Arrowhead audits and inspections
• Assist with preparation, update, review, and routing of Arrowhead procedural documents
• Support eQMS and other system implementations.
• Perform additional QA duties as needed.

Requirements

• Associate's degree, with BS/BA preferred.
• 1+ year of quality assurance experience
• Ability to follow company procedures, work instructions, and policies.
• Competent knowledge of and ability to use Microsoft Word, Outlook, PowerPoint and Excel.
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize work with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.

Preferred

• Experience working in biotech or pharmaceutical development, manufacturing, or contract manufacturing organizations
• Working knowledge of GMP, GCP, and/or GLP regulations.
• Prior experience with use of an electronic document management system in a regulated environment.

California pay range

$68,000—$80,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.

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