The Position 

The purpose of this position is to provide quality assurance support to programs utilizing contract development, manufacturing, and testing organizations. The incumbent will review vendor documentation and perform lot disposition per applicable quality agreements as well as capture quality data and generate metrics for vendors. The incumbent will be expected to interact with internal departments as well as multiple contract organizations to support ongoing pre-clinical and clinical development programs at Arrowhead Pharmaceuticals, Inc.

Responsibilities

• Interact with personnel companywide to obtain the necessary information and details to provide quality assurance support of development, clinical, and commercial programs
• Review and approve vendor generated documentation, including but not limited to, master and executed batch records, testing records, certificates of analysis (CoA), labels, protocols, and reports
• Collaborate with vendors on quality events and non-conformances as outlined in the applicable quality agreement
• Perform lot disposition and generate certificates of compliance (CoC) as necessary
• Assist with tracking vendor quality metrics; notify QA management of any performance issues
• Assist with preparation, update, review, and routing of Arrowhead procedural documents
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval
• Draft, review, and approve standard operating procedures (SOP) and work instructions (WI) as needed
• Assist with QA duties as needed.
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Requirements:

• BS/BA degree
• Minimum of 5 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization
• Working knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents
• 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
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Preferred: 

• Degree in an applicable scientific field such as chemistry, biology, or biochemistry
• Prior experience with use of an electronic document management system in a regulated environment