Senior Quality Assurance Specialist

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 and San Diego, CA. 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 within the Quality Assurance department is to support on-going development programs for preclinical and clinical drug candidates as well as commercial candidates at Arrowhead. The candidate will be expected to interact with multiple internal departments, as well as assist with quality oversight functions for external organizations.

Responsibilities

• Review and approval of internal and vendor generated documentation, including master batch records, executed batch records, labels, certificates, reports, and testing records.
• Review and release of completed manufacturing batch documentation including Quality Control data and issuance of Certificates of Analysis.
• Writing, review, change control, approval, issuance, and organization of applicable Standard Operating Procedures (SOPs).
• Issuance, review, tracking, and completion of internal deviations, out of specifications, and CAPAs.
• Organization and control of quality, compliance, and project related documentation.
• Auditing of vendor and internal documentation and files.
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development
• Collaborate with, and provide quality support for, other departments (QC, Project Management, Toxicology, Clinical Operations, Supply Chain, etc.)
• Participate in meetings with vendors and external organizations as the QA team representative.
• Other duties consistent with the position as assigned from time to time.

Requirements:

• Minimum of 8 years of auditing experience in a pharmaceutical development company and/or contract manufacturing organization.
• Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.

Preferred:

• Experience with quality systems supporting drug-device combination products per 21 CFR Part 3 and medical devices QSR per 21 CFR Part 820/ISO 13485
• Bachelors Degree

Wisconsin pay range

$85,000-$115,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

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