Quality Assurance Specialist II - External Quality

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, capture quality data, and generate metrics for vendors. Expected to interact with internal departments and contract organizations to support ongoing commercial, pre-clinical, and clinical development programs.

• Interact with personnel company wide to obtain information needed for QA support of development, clinical, and commercial programs.
• Review and approve vendor-generated documentation (e.g., executed batch records, testing records, CoA, labels, protocols, and reports).
• Collaborate with vendors on quality events and non-conformances per the applicable quality agreement.
• 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 EDMS, properly categorize, and route for verification/approval.
• Assist with QA duties as needed.

• BS/BA in an applicable scientific field (chemistry, biology, or biochemistry).
• Minimum 3 years QA or similar experience in biotech/pharma development, manufacturing, or contract manufacturing.
• Working knowledge of GMP, GCP, and/or GLP; ICH and FDA guidance.
• Excellent interpersonal, verbal, and written communication.
• Ability to follow procedures/work instructions/policies.
• Excellent attention to detail and organizational skills.
• Ability to work independently with minimal supervision and manage priorities in a fast-paced environment.

• Experience using an electronic document management system in a regulated environment.
• Proficiency with Adobe Acrobat, Microsoft Office, and Smartsheet.

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