Quality Assurance Specialist II - Internal Quality
Arrowhead Pharmaceuticals
August 21, 2026
On-site
Madison, WI
Operations
Responsibilities:
- Interact with manufacturing, QC, and Analytical Development to gather documentation for review.
- Review and approve analytical testing data and final reports (internal/external) with minimal supervision.
- Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
- Review and approve internally generated raw material data/documentation with minimal supervision.
- Perform lot disposition/release of raw materials; perform room releases and QA on the floor as required.
- Assist with investigations and deviations; organize and control project documentation.
- Issue, review, and reconcile controlled forms; review/verify/reconcile labels.
- Scan/upload executed documents to EDMS, categorize, and route for verification/approval.
- Maintain knowledge of drug development compliance; assist with GDoc practices, GMP, and data integrity training.
- Additional duties as assigned.
Requirements:
- BS/BA in chemistry, biology, biochemistry (or applicable scientific field).
- 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.
- Strong interpersonal, verbal, and written communication; professional external communications.
- Follow procedures and policies; attention to detail; organizational skills.
- Ability to work independently with minimal supervision and manage priorities in a fast-paced environment.
Preferred:
- Quality systems experience supporting GMP regulations (21 CFR Parts 11, 210, 211; EU GMP incl. Annex 11 & 15).
- Microsoft Word/Excel/Smartsheet; EDMS experience in regulated environments.
Pay/Benefits:
- Wisconsin pay range: $70,000–$85,000.
- Competitive salaries and an excellent benefit package.
Application instructions:
- Must have current, valid authorization to work in the country where the role is located.
- Interact with manufacturing, QC, and Analytical Development to gather documentation for review.
- Review and approve analytical testing data and final reports (internal/external) with minimal supervision.
- Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
- Review and approve internally generated raw material data/documentation with minimal supervision.
- Perform lot disposition/release of raw materials; perform room releases and QA on the floor as required.
- Assist with investigations and deviations; organize and control project documentation.
- Issue, review, and reconcile controlled forms; review/verify/reconcile labels.
- Scan/upload executed documents to EDMS, categorize, and route for verification/approval.
- Maintain knowledge of drug development compliance; assist with GDoc practices, GMP, and data integrity training.
- Additional duties as assigned.
Requirements:
- BS/BA in chemistry, biology, biochemistry (or applicable scientific field).
- 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.
- Strong interpersonal, verbal, and written communication; professional external communications.
- Follow procedures and policies; attention to detail; organizational skills.
- Ability to work independently with minimal supervision and manage priorities in a fast-paced environment.
Preferred:
- Quality systems experience supporting GMP regulations (21 CFR Parts 11, 210, 211; EU GMP incl. Annex 11 & 15).
- Microsoft Word/Excel/Smartsheet; EDMS experience in regulated environments.
Pay/Benefits:
- Wisconsin pay range: $70,000–$85,000.
- Competitive salaries and an excellent benefit package.
Application instructions:
- Must have current, valid authorization to work in the country where the role is located.