Quality & Compliance
Associate Engineer, Quality Assurance Engineering
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 within the Quality Assurance department will support on-going development programs for preclinical and clinical drug candidates at Arrowhead. A key function of the position will involve continued development and maintenance of quality systems supporting Good Manufacturing Practices (GMP) within the organization. Functions of this position will include interaction with multiple internal departments to draft, review, and approve procedures and processes, serving as the Quality Assurance subject matter expert (SME) in qualification and validation efforts, review and approval of system and process lifecycle documentation, release of systems for use, and general quality assurance auditing of metrology records and analytical data.
Responsibilities
- Serve as the Quality Assurance lead for system or process validation; this includes providing guidance, review, and approval of activities such as system requirements engineering, process design, risk assessments, and supporting validation documentation
- Serve as the Quality Assurance lead for maintaining system or process data integrity
- Provide support for the issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs
- Draft, review, and approve procedures in support of quality systems and validated systems and processes
- Support the development and implementation periodic reviews for validated systems or processes
- Review and approval of internal and vendor generated data and documentation in support of validation, qualification, and commissioning activities for equipment, instruments, and facilities
- Final release for use of systems and instruments
- Support utilization of an electronic document management system (Veeva QualityDocs)
- Perform release of controlled documents such as logbooks and other forms, as well as a final quality review on completed forms, weight set verifications, and label reconciliations
- Prepare documentation and provide support for internal and external audits
- Other duties, consistent with the position, as assigned
Requirements:
- At least 4 years of experience working on systems validation in an FDA-regulated environment with preference to quality assurance positions
- Working knowledge of drug Good Manufacturing Practices (GMP) regulations (21CFR Parts 11, 210, 211, and EU GMPs, including Annex 11 and 15)
- Competent knowledge of and ability to use Microsoft Word and Excel
- Ability to follow company procedures, work instructions, and policies
- Excellent attention to detail and organizational skills
- Ability to multi-task and prioritize work tasks with minimal supervision
- Excellent interpersonal, verbal, and written communication skills
- Work in a safe manner; properly handle materials and chemicals
Preferred:
- A bachelor’s degree, or higher, in a science field
- 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.