<p>The Position</p> <p>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.</p> <p>Responsibilities</p> <ul> <li>Review and approve incoming raw material supplier documentation along with internally generated testing documentation and perform lot disposition of incoming raw materials. </li><li>Collaborate with raw material suppliers on quality events and non-conformances and as outlined in the applicable quality agreements. </li><li>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. </li><li>Update raw material specification documents with onboarding new suppliers and as part of periodic review. </li><li>Capture raw material supplier quality data and generate metrics. </li><li>Assist with review of raw material qualifications. </li><li>Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval. </li><li>Assist with preparation, update, review, and routing of Arrowhead procedural documents. </li><li>Assist with other QA duties as needed. </li></ul> <p>Requirements</p> <ul> <li>BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred </li><li>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. </li><li>Working knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents. </li><li>Prior experience with use of an electronic document management system in a regulated environment. </li><li>Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and SmartSheet. </li><li>Excellent interpersonal, verbal, and written communication skills. </li><li>Ability to consistently communicate with external parties in a professional manner. </li><li>Ability to follow company procedures, work instructions, and policies. </li><li>Excellent attention to detail and organizational skills. </li><li>Ability to work independently with minimal supervision as well as manage priorities within a face paced environment. </li></ul>