Quality & Compliance
Specialist, Veeva Coordinator
Office Location: Verona, WI
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 and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
This position will assist Quality Assurance with Quality Management System (QMS) activities at Arrowhead Pharmaceuticals. The incumbent will track project status updates, as appropriate, as well as assist with new system implementations with direction of QA management. The incumbent may also assist with document control by drafting new procedures, updating existing documents within Arrowhead’s quality systems, and coordinating workflows on behalf of the company.
Responsibilities
- Work with colleagues to ensure quality systems meet standards for business needs.
- Assist with preparation, update, review, and routing of Arrowhead procedural documents.
- Build and maintain reports to send out to business partners regarding quality metrics.
- Upload documents to Arrowhead’s EDMS, Veeva QualityDocs, and coordinate workflows.
- Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
- Write standard operating procedures and work instructions as needed for all types of quality systems and practices.
- Assist with Veeva and other system implementations.
- Assist with issuance of controlled forms, notebooks, etc.
- Assist with QA duties as needed.
Requirements:
- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred
- Working knowledge of GMP, GCP, and/or GLP regulations.
- Prior experience with use of an electronic document management system in a regulated environment.
- Competent knowledge of, and ability to use and format within Adobe Acrobat and Microsoft Office.
Preferred:
- Preferred 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.
- Excellent attention to detail and organizational skills.
- Ability to multi-task and prioritize work with minimal supervision.
- Excellent interpersonal, verbal, and written communication skills.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.