Senior Specialist, Quality Assurance (2nd Shift)

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 within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. A key function of the position will involve continued development and maintenance of quality systems supporting Good Manufacturing Practices (GMP) within the organization. The Senior Specialist is expected to interact with multiple internal departments, as well as assist with quality oversight functions for external organizations.

2nd shift work hours are ~1pm - 11 : 30pm and includes a 10% shift differential.

Responsibilities

• Review and approval of internal and vendor generated documentation, including master batch records, executed batch records, labels, certificates, reports, and testing records.
• Perform QA on the floor and manufacturing room release.
• Review and release of completed manufacturing batch documentation including Quality Control (QC) and Analytical Development (AD) data and issuance of Certificates of Analysis.
• Writing, review, change control, approval, issuance, and organization of applicable procedural documents.
• Issuance, review, tracking, and completion of internal quality events (QEs), such as deviations, out of specifications (OOS), and CAPAs.
• Organization and control of quality, compliance, and project related documentation.
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
• Collaborate with, and provide quality support for, other departments (Manufacturing, QC, AD, Project Management, etc.).
• Participate in meetings as the QA team representative as needed.
• Additional duties as assigned.

Requirements :

Preferred

Wisconsin pay range

$90,000-$110,000 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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