ppArrowhead 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. /p pArrowhead 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. /p pArrowhead’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. /p h3The Position /h3 pThe 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.



Key functions of this position may involve review of manufacturing batch records, analytical data and reports, associated documents and other activities needed to support operations within the Quality Assurance department and will also support general quality systems related to current Good Manufacturing Practices (cGMP) within the organization. The Specialist II is expected to interact with multiple internal departments. /p h3Responsibilities /h3 ul liInteract with representatives from other departments, including manufacturing, QC, and Analytical Development, to obtain the necessary information for review of documentation. /li liReview and approve analytical testing data and final reports from internal and external sources with minimal supervision. /li liReview and approve manufacturing batch records, forms, and associated testing with minimal supervision. /li liReview and approve internally generated raw material data and documentation with minimal supervision. /li liPerform lot disposition and release of raw materials with minimal supervision. /li liPerform room releases as required. /li liPerform QA on the floor as required. /li liAssist with investigations and deviations as appropriate with minimal supervision. /li liOrganization and control of project related documentation. /li liIssue, review, and reconcile controlled forms. /li liReview, verify, and reconcile labels. /li liScan and upload executed documents to the EDMS, properly categorize within the system,



and route for verification/approval. /li liMaintain knowledge of current compliance expectations and regulations pertaining to drug development. /li liAssist with Good Documentation Practices, GMP, and data integrity training as needed. /li liAdditional duties as assigned. /li /ul h3Requirements /h3 ul liBS/BA in an applicable scientific field such as chemistry, biology, or biochemistry /li liMinimum of 3 years of quality assurance or similar experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization. /li liWorking knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents. /li liExcellent interpersonal, verbal, and written communication skills. /li liAbility to consistently communicate with external parties in a professional manner. /li liAbility to follow company procedures, work instructions, and policies. /li liExcellent attention to detail and organizational skills. /li liAbility to work independently with minimal supervision as well as manage priorities within a fast-paced environment. /li /ul h3Preferred /h3 ul liExperience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15). /li liCompetent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet. /li liPrior experience with use of an electronic document management system in a regulated environment. /li /ul pWisconsin pay range /p p$70,000—$85,000 USD /p pArrowhead provides competitive salaries and an excellent vantaggi package. /p pCandidates must have current, valid authorization to work in the country where this role is located. /p pCalifornia Applicant Privacy Policy /p /p #J-18808-Ljbffr

📌 Quality Assurance Specialist II - Internal Quality (Verona)
🏢 Arrowhead Pharmaceuticals
📍 Verona