Senior Specialist, Quality Assurance

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.
• Perform lot disposition and generate certificates of compliance (CoC) as necessary.
• Collaborate with vendors on quality events and non-conformances as outlined in the applicable quality agreement.
• Review and release of completed manufacturing batch documentation including Quality Control data and issuance of Certificates of Analysis.
• Organization and control of quality, compliance, and project related documentation.
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development
• Collaborate with, and provide quality support for, other departments (QC, Project Management, Toxicology, Clinical Operations, Supply Chain, etc.)
• Participate in meetings with vendors and external organizations as the QA team representative.
• Other duties consistent with the position as assigned from time to time.
• Assist with tracking vendor quality metrics; notify QA management of any performance issues.
• Assist with preparation, update, review, and routing of Arrowhead procedural documents.
• Draft, review, and approve standard operating procedures (SOP) and work instructions (WI) as needed.
• Assist with QA duties as needed.

Requirements

• 8 years of quality assurance experience in a pharmaceutical development company and/or contract manufacturing organization.
• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
• Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
• Excellent written and verbal communication skills and ability to communicate with internal and external parties.
• Highly motivated team player willing to contribute to a growing pharmaceutical organization.
• Ability to work independently with minimal supervision and as well as manage priorities within a fast-paced environment.
• A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead

Preferred: 

• Previous experience with quality systems supporting drug-device combination products per 21 CFR Part 3 and medical devices QSR per 21 CFR Part 820/ISO 13485 is preferred.
• Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and SmartSheet.