Quality & Compliance
Quality Assurance Specialist (Raw Materials)
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
The purpose of this position is to provide quality assurance support to the raw materials program. This person will review raw material supplier documentation and perform lot disposition per applicable quality agreements as well as capture quality data and generate metrics for suppliers. This person will be expected to interact with internal departments as well as multiple contract organizations to support ongoing pre-clinical and clinical development as well as commercial programs at Arrowhead Pharmaceuticals, Inc.
Responsibilities
- Review and approve incoming raw material supplier documentation along with internally generated testing documentation and perform lot disposition of incoming raw materials.
- Collaborate with raw material suppliers on quality events and non-conformances and as outlined in the applicable quality agreements.
- Request supporting documentation for raw material qualification from suppliers, including but not limited to, production records, certificates of analysis (CoA), certificates of conformance (CoC), BSE/TSE statements, etc.
- Update raw material specification documents with onboarding new suppliers and as part of periodic review.
- Capture raw material supplier quality data and generate metrics.
- Assist with review of raw material qualifications.
- Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
- Assist with preparation, update, review, and routing of Arrowhead procedural documents.
- Assist with other QA duties as needed.
Requirements
- BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred
- 3 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization with an emphasis on raw material release activities.
- Working knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents.
- Prior experience with use of an electronic document management system in a regulated environment.
- Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and SmartSheet.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to consistently communicate with external parties in a professional manner.
- Ability to follow company procedures, work instructions, and policies.
- Excellent attention to detail and organizational skills.
- Ability to work independently with minimal supervision as well as manage priorities within a face paced environment.
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.