Data Reviewer, Quality Control

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hedht

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 Data Reviewer independently performs technical review of laboratory data and documentation to ensure compliance with analytical methods, specifications, GMP/GDP requirements, and data integrity standards. This role exercises independent judgment in evaluating data quality, identifying discrepancies, and resolving routine to moderately complex compliance issues. The Data Reviewer supports inspection readiness activities, contributes to continuous improvement initiatives, and serves as a technical resource to junior team members. /p h3Responsibilities: /h3 ul liPerform independent technical review of internal data and external laboratory data /li liEvaluate data for accuracy, completeness, and compliance with GMP and specifications /li liIndependently evaluate, investigate, and document discrepancies, atypical results, and documentation inconsistencies to determine impact and ensure appropriate resolution /li liReview routine release and stability data, method validation data and report, IPC data, cleaning samples,



and logbooks for traceability and compliance /li liCommunicate and collaborate with laboratory staff and CDMOs to resolve data quality issues /li liSupport audit readiness activities and participate in inspections /li liMaintain knowledge of laboratory systems and software for effective review /li liRecommend and support implementation of improvements to data review processes, documentation practices, and workflow efficiency /li liProvide guidance and onboarding support to junior reviewers on review practices, documentation standards, and GMP expectations /li liEmbrace digital tools and opportunities for trend analysis, system suitability trending. /li liPerform additional duties as assigned in support of operations /li /ul h3Requirements: /h3 ul liBachelor’s degree in chemistry or (any STEM degree) and 5+ years GMP experience, or a Master of Science (STEM degree) with minimum 3 years of experience in a cGMP laboratory (pharmaceutical CMO/CRO). /li liExperience with analytical data review and documentation practices /li liWorking knowledge and experience with chemistry analytical methods such as HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry and microbiology testing. /li liWorking knowledge of GMP/GDP and laboratory systems /li /ul h3Preferred /h3 ul liWorking knowledge of USP, ISO, FDA and ICH guidelines /li liFamiliarity with laboratory information systems, LIMS. /li liStrong verbal and written communication skills and ability to work with diverse professionals in a matrix environment. /li liSolid organizational skills with ability to adapt to changing priorities and deadlines. /li /ul h3Wisconsin pay range /h3 p$80,000—$90,000 USD /p pArrowhead provides competitive salaries and an excellent agevolazioni 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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hedht