Quality Specialist III, GxP Conformity & Continuous Improvement

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

The QA Specialist III role is responsible for supporting Quality Events, including laboratory investigations, deviations, continuous improvement initiatives, and CAPAs within Arrowhead Pharmaceutical's eQMS (Veeva). This position will ensure that timely, efficient, and thorough investigations are conducted for conformance events, assess the suitability and adequacy of determined subsequent actions, and support continued tracking/trending of quality metrics. 

Responsibilities

• Support eQMS workflows related to Quality Events. 
• Review, track, and approve Quality Events within eQMS. 
• Support operations with investigations, identifying root cause and determination of corrective and preventive actions.
• Review adequacy of CAPAs. 
• Support quality review board activities by preparing data and tracking follow-up actions. 
• Identify, communicate, and escalate with internal stakeholders observed trends.
• Prepare and present data and trends to internal stakeholders. 
• Interact with representatives from other departments to investigate and close QEs within the eQMS. 
• Write, review, and approve procedural documents. 
• Participate and support audits and inspections. 
• Ensure compliance with applicable regulations, international standards, and internal procedures. 
• Assist with other QA duties as needed. 

Requirements

• 6 years of experience working in a regulated environment, with a preference for quality assurance auditing.
• Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
• Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.

Preferred

• Bachelor's degree
• Prior experience with use of an electronic document and/or quality management system in a regulated environment
• Previous 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.

Wisconsin pay range

$78,000—$98,000 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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