Senior Data Reviewer, Quality Control

Arrowhead Pharmaceuticals•Verona, WI

9h•$95,000 - $110,000

About The Position

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 Senior Data Reviewer is responsible for ensuring the accuracy, completion, quality, and compliance of laboratory data and reports produced within the Quality Control (QC) team. Key functions of this position include the technical review of internal and external analytical testing data, related documentation, validations, and reports to ensure compliance with analytical methods and specifications. The ideal candidate will have demonstrated experience with analytical testing, either in performance or technical review

Requirements

Bachelor of Science in Chemistry or (any STEM degree) with minimum 8 years of experience), or a Master of Science (STEM degree) with minimum 5 years of experience in a cGMP laboratory (pharmaceutical CMO/CRO).
Hands-on experience in analytical chemistry and compendial testing. Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review.
Working knowledge and experience with chemistry analytical methods such as HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry and microbiology testing.

Nice To Haves

Working knowledge of USP, ISO, FDA and ICH guidelines
Familiarity with laboratory information systems.
Strong verbal and written communication skills and ability to work with diverse professionals in a matrix environment.
Solid organizational skills with ability to adapt to changing priorities and deadlines.

Responsibilities

Evaluate data and reports from external testing laboratories and CDMOs to ensure compliance with specifications and Good Documentation Practices (GDP) and adherence to Data Integrity requirements.
Ensure documentation, data, and records are complete, accurate, and maintained in a state of inspection readiness to support business needs and regulatory audits.
Perform timely technical review of cleaning samples and In-Process Control (IPC) data in support of Manufacturing.
Review reagent and equipment logbooks to verify traceability, compliance, and operational consistency.
Understand and acquire knowledge to effectively navigate associated laboratory software systems and equipment interfaces, enabling thorough and technically sound record review.
Embrace digital tools and opportunities to leverage advanced analytics and generative AI enabled solutions to enhance documentation review, trend analysis, deviation investigations, and overall laboratory performance.
Support internal and external audits, including audit preparation activities and direct support during inspections.
Follow all relevant GxP regulations, guidelines, and company policies to ensure full compliance with regulatory and internal requirements.
Work directly with management to ensure QC goals and milestones are met, proactively identifying risks and mitigation strategies.
Complete all required training and assigned learning plans according to defined due dates and prescribed requalification cadence.
Perform additional duties as assigned in support of QC operations.
Assist data reviewers with troubleshooting and technical reviews
Train and mentor data reviewers