Senior Quality Assurance Specialist

The Position

The purpose of this position is to provide quality assurance support to programs utilizing contract development, manufacturing, and testing organizations. This role is part of a team that oversees all aspects of supplier quality. This person will be expected to interact with contract organizations as well as internal departments to support ongoing pre-clinical and clinical development as well as commercial programs at Arrowhead Pharmaceuticals, Inc. 

Responsibilities

• Complete requests for supplier documentation in support of supplier maintenance activities.
• Perform quality agreement lifecycle management, including but not limited to, drafting, editing, reviewing, approving, and ensuring compliance with periodic review cycles.
• Review, approve, categorize, and maintain supplier documentation, including but not limited to, questionnaires, registration documents, accreditations, certifications, BSE/TSE statements, etc.
• Collaborate with QA teammates and supplier quality assurance representatives on supplier quality events and non-conformances as outlined in the applicable quality agreements.
• Capture supplier quality data and generate metrics.
• Scan and upload 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 QA duties as needed.

Requirements:

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred
• 8 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.
• 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, DocuSign, 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.