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Form of workJob Description
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
The purpose of this position within the Quality Assurance department is to support ongoing development programs for preclinical and clinical drug candidates at Arrowhead. A key function of the position will involve continued development and maintenance of ongoing and completed stability studies within the Quality Assurance department and will also support general quality systems related to Good Manufacturing Practices (GMP) within the organization. The candidate will be expected to interact with multiple internal departments.
Responsibilities
- Review and perform QA disposition of all incoming raw materials intended for GMP manufacturing, including proper labeling of packaging/containers (Released, Quarantine, Rejected) according to Arrowhead Quality Procedures
- Interact with representatives from other departments, including QC and Analytical Development, to obtain the necessary information for review of documentation
- Review and approve analytical testing data and final reports from internal and external sources
- Assist with investigations and deviations, as appropriate
- Organization and control of project related documentation
- Perform release of controlled documents such as logbooks and other forms, as well as a final quality review on completed forms, weight set verifications, label reconciliations
- Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval
- Maintain knowledge of current compliance expectations and regulations pertaining to drug development
- Additional duties as assigned
Requirements:
- A Bachelor's degree in a science field
- At least three years of experience working in a regulated environment with preference to Quality Assurance auditing and/or raw material experience
- Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents
- Competent knowledge of and ability to use Microsoft Word and Excel and Smartsheet
- Ability to follow company procedures, work instructions, and policies
- Work in a safe manner; properly handle materials and chemicals
- 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
Preferred:
- Previous experience with quality systems supporting drug-device combination products per 21 CFR Part 3 and medical devices QSR per 21 CFR Part 820/ISO 13485
- 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.
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