Quality Assurance Specialist II — Biotech GMP Focus

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI seeks a Quality Assurance professional to support development, clinical, and commercial programs.

You will review vendor documentation, perform lot disposition, and generate certificates of compliance while coordinating with internal teams and contract organizations. The role requires a BS/BA in a scientific field, 3+ years in biotech QA, and strong knowledge of GMP/GCP/GLP and ICH/FDA guidance.

Qualifications

• BS/BA in chemistry, biology, or biochemistry.
• 3+ years in QA in biotech/pharma development or contract manufacturing.
• Knowledge of GMP, GCP, GLP, ICH and FDA guidance.
• Excellent communication and organizational skills.
• Ability to work independently in a fast-paced environment.

Responsibilities

• Provide QA support for development, clinical, and commercial programs.
• Review and approve vendor documentation (CoA, batch records, labels, reports).
• Collaborate with vendors on quality events and non-conformances.
• Perform lot disposition and issue certificates of compliance.
• Assist with QA duties and procedure document control.
• Manage EDMS document uploading and routing.

Skills

Quality Assurance

Communication skills

Attention to detail

Independent work

Education

BS/BA in chemistry/biology/biochemistry

Tools

EDMS

Adobe Acrobat

Microsoft Office

Smartsheet

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI seeks a Quality Assurance professional to support development, clinical, and commercial programs.

You will review vendor documentation, perform lot disposition, and generate certificates of compliance while coordinating with internal teams and contract organizations. The role requires a BS/BA in a scientific field, 3+ years in biotech QA, and strong knowledge of GMP/GCP/GLP and ICH/FDA guidance.