Quality & Compliance
Specialist, Training & Documentation
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 compliance activities at Arrowhead Pharmaceuticals. The incumbent will track training for employees, as appropriate., as well as keep updated training documentation for all staff within Arrowhead’s quality systems under the direction of QA management. The incumbent may also assist with document control by drafting new procedures, updating existing documents within Arrowhead’s quality systems, issuing controlled documentation, and maintaining archival of completed documentation.
Responsibilities
- Manage employee’s training files and job descriptions within Arrowhead’s EDMS
- Issue controlled forms, notebooks, etc
- Assist with preparation, update, review, and routing of Arrowhead procedural documents
- Assist QA management with the implementation and upkeep of a LMS (Learning Management System), including development and management of training curricula, driving consistency across departments, and ensuring access to proper leaning materials
- Track and report on training compliance; notify management of over-due employee training requirements
- Interact with personnel companywide to obtain the necessary information and details for preparing training records
- Upload documents to Arrowhead’s EDMS, Veeva QualityDocs, and route for electronic approval
- Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval
- Manage and ensure timely review of periodic review assignment within the EDMS
- 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 QA duties as needed
Requirements:
- Minimum of an Associate degree in applicable science field
- Preferred experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization writing and maintaining documents
- Working knowledge of GMP, GCP, and/or GLP regulations
- Competent knowledge of, and ability to use and format within Adobe Acrobat and Microsoft Office
Preferred:
- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
- 3 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization writing and maintaining documents
- Prior experience with use of an electronic document management system in a regulated environment
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.