<p>The Position</p> <p>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.</p> <p>Responsibilities</p> <ul> <li>Serve as the Quality Assurance subject matter expert on system and process validations. This includes providing guidance, review, and approval of activities such as system requirements engineering, process design, risk assessments, and supporting validation documentation. </li><li>Serve as the Quality Assurance lead for maintaining system or process data integrity. </li><li>Provide support for the issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs. </li><li>Draft, review, and approve procedures in support of quality systems and validated systems and processes. </li><li>Support the development and implementation periodic reviews for validated systems or processes. </li><li>Work with team members in the review and approval of internal and vendor generated data and documentation in support of validation, qualification, and commissioning activities for equipment, instruments, and facilities. </li><li>Final release for use of systems and instruments. </li><li>Support utilization of an electronic document management system (Veeva QualityDocs). </li><li>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. </li><li>Prepare documentation and provide support for internal and external audits. </li><li>Other duties, consistent with the position, as assigned. </li></ul> <p>Requirements:</p> <ul> <li>A bachelor's degree, or higher, in a science field. </li><li>4 years of experience working with cGMP-regulated manufacturing and Process Lifecycle, with preference to quality assurance positions. </li><li>Working knowledge of drug Good Manufacturing Practices (GMP) regulations (21CFR Parts 11, 210, 211, and EU GMPs, including Annex 11 and 15). </li></ul> <p>Preferred:</p> <ul> <li>Competent knowledge of and ability to use Microsoft Word and Excel. </li><li>Ability to follow company procedures, work instructions, and policies. </li><li>Excellent attention to detail and organizational </li><li>Ability to multi-task and prioritize work tasks with minimal </li><li>Excellent interpersonal, verbal, and written communication skills </li><li>Prior experience with the use of an electronic document management system in a regulated environment is preferred. </li></ul>