Quality Assurance Specialist II - External Quality

About the role

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them. Using RNA interference (RNAi) technologies, Arrowhead therapies induce rapid, deep, and durable knockdown of target genes. The company focuses on innovative drugs for genetically based diseases, addressing conditions across therapeutic areas and pursuing targets not otherwise addressable by small molecules and biologics.

This position provides quality assurance support for programs utilizing contract development, manufacturing, and testing organizations. The incumbent will review vendor documentation, perform lot disposition, capture quality data, and generate metrics for vendors while collaborating with internal teams and external contract organizations to support commercial, pre-clinical, and clinical development programs.

Responsibilities

• Interact with personnel companywide to obtain information and details for quality assurance support of development, clinical, and commercial programs.
• Review and approve vendor-generated documentation, including 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 applicable quality agreements.
• Perform lot disposition and generate certificates of compliance (CoC) as necessary.
• Assist with preparation, update, review, and routing of Arrowhead procedural documents.
• Scan and upload executed documents to the EDMS, categorize them properly, and route for verification/approval.
• Assist with additional QA duties as needed.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry.
• Minimum of 3 years of quality assurance or similar 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.
• 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 and manage priorities in a fast-paced environment.

Preferred Qualifications

• Prior experience with an electronic document management system in a regulated environment.
• Competent knowledge of Adobe Acrobat, Microsoft Office programs, and Smartsheet.

Pay

Wisconsin pay range: $70,000 USD - $85,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.