Quality Assurance Specialist II - External Quality
Arrowhead Pharmaceuticals
August 21, 2026
Remote friendly (Madison, WI)
United States
Operations
Responsibilities:
- Interact with personnel companywide to obtain information needed 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 per 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 properly, and route for verification/approval.
- Assist with QA duties as needed.
Requirements:
- BS/BA in an applicable scientific field (e.g., chemistry, biology, biochemistry).
- Minimum 3 years of quality assurance or similar experience in biotech/pharmaceutical development, manufacturing, or contract manufacturing.
- Working knowledge of GMP, GCP, and/or GLP; ICH and FDA guidance documents.
- Excellent interpersonal, verbal, and written communication.
- Ability to communicate professionally with external parties.
- 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:
- Prior experience using an electronic document management system (regulated environment).
- Proficient with Adobe Acrobat, Microsoft Office, and Smartsheet.
Pay/benefits:
- Wisconsin pay range: $70,000 USD - $85,000 USD.
- Competitive salaries and an excellent benefit package.
- Interact with personnel companywide to obtain information needed 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 per 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 properly, and route for verification/approval.
- Assist with QA duties as needed.
Requirements:
- BS/BA in an applicable scientific field (e.g., chemistry, biology, biochemistry).
- Minimum 3 years of quality assurance or similar experience in biotech/pharmaceutical development, manufacturing, or contract manufacturing.
- Working knowledge of GMP, GCP, and/or GLP; ICH and FDA guidance documents.
- Excellent interpersonal, verbal, and written communication.
- Ability to communicate professionally with external parties.
- 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:
- Prior experience using an electronic document management system (regulated environment).
- Proficient with Adobe Acrobat, Microsoft Office, and Smartsheet.
Pay/benefits:
- Wisconsin pay range: $70,000 USD - $85,000 USD.
- Competitive salaries and an excellent benefit package.