Quality Assurance Specialist II at Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals · Madison, United States Of America · Onsite
- Professional
- Office in Madison
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 & 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
The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. A key function of the position will involve review of manufacturing batch records, analytical data and reports, and associated documents within the Quality Assurance department and will also support general quality systems related to current Good Manufacturing Practices (cGMP) within the organization. The Specialist II is expected to interact with multiple internal departments.
Key Duties and Responsibilities:
- Interact with representatives from other departments, including manufacturing, 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 with minimal supervision.
- Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
- Perform room releases as required.
- Perform QA on the floor as required.
- Assist with investigations and deviations as appropriate with minimal supervision.
- Organization and control of project related documentation.
- Issue, review, and reconcile controlled forms.
- Review, verify, and reconcile labels.
- 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.
- Assist with Good Documentation Practices, GMP, and data integrity training as needed.
- Additional duties as assigned.
Minimum Qualifications and Educational Requirements:
- Minimum of a bachelor’s degree in a science discipline, or equivalent required.
- Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
Preferred Qualifications and Competency Requirements:
- Minimum of three years of experience working in a regulated environment with preference to quality assurance auditing and/or manufacturing experience.
- Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15).
- Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.
- Prior experience with use of an electronic document management system in a regulated environment is preferred.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
