Quality Specialist III, Document Control and Training

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

Serve as an individual contributor supporting the day-to-day execution of controlled documentation and training compliance activities within the Quality Assurance function. Process and maintain controlled documents, quality records, and training records within the eQMS and learning management system, ensuring accuracy, completeness, and compliance with applicable regulatory requirements. Support the issuance, reconciliation, and review of applicable controlled documents to ensure traceability of applicable GxP documentation.

Responsibilities

Document Control and Records Management

• Support document formatting, metadata entry, routing, approval workflows, effective date coordination, periodic review activities, and controlled document lifecycle maintenance.
• Support issuance, reconciliation, and review of controlled documents and completed records to verify completeness and compliance with GDocP requirements.
• Maintain organized and audit-ready document control files, including effective documents, superseded or obsolete records, document change records, and supporting documentation.
• Support preparation and organization of document control packages for internal audits, client audits, regulatory inspections, and document change control activities.
• Assist with controlled copy management, document distribution, retrieval, archival, and record retention activities, as applicable.
• Assist with the development, revision, and maintenance of document control work instructions and SOPs, as directed.
• Support formatting and routing of corporate policies through approval workflows, and coordinate periodic review timing with Legal, Health Care Compliance, IS&I and applicable stakeholders.
• Perform additional duties as assigned.

Training Administration and Compliance

• Monitor training completion rates, identify at-risk or past-due training items, and proactively escalate concerns, as applicable.
• Assist in developing and updating training materials, including slide decks, assessments, and Read-and-Understand documents for GxP and SOP-based training programs.
• Support new hire orientation and classroom training activities.
• Compile and organize training completion data and generate routine compliance reports for review by management.
• Maintain training records in an organized, accurate, and audit-ready state.
• Perform additional duties as assigned.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
• Minimum of 5 years of experience in a pharmaceutical/biotech company, contract manufacturing organization or contract research organization writing and maintaining documents.
• Ability to follow company procedures, work instructions, and policies.
• Ability to multi-task and prioritize work with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.
• Strong organizational skills with the ability to manage multiple tasks, prioritize workload, and meet competing deadlines.

Preferred

• Experience with an eQMS/eDMS platform (e.g., Veeva) and/or LMS software in a GxP-regulated environment.
• Working knowledge of GMP, GCP, and/or GLP regulations.
• Competent knowledge of, and ability to use, Adobe Acrobat, Microsoft Word, PowerPoint and Excel.

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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