Quality Assurance Specialist II - GMP & Documentation Expert

Arrowhead Pharmaceuticals, Inc.; Madison (WI); On-site; USD 75,000 - 105,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking a Quality Assurance Specialist II to support preclinical, clinical, and commercial drug candidates. You will review manufacturing batch records, analytical data, and reports, helping ensure compliance with cGMP and related quality systems.

The role requires a BS/BA in a scientific field, 3+ years in QA within biotech/pharma, and strong communication skills. Experience with GMP, GCP, GLP, ICH, and FDA guidance is preferred.

Qualifications

• BS/BA in a scientific field such as chemistry, biology, or biochemistry.
• Minimum of 3 years of quality assurance experience in biotech/pharma.
• Knowledge of GMP, GCP, GLP and ICH/FDA guidance.
• Strong written and verbal communication and attention to detail.

Responsibilities

• Review and approve analytical testing data and final reports with minimal supervision.
• Review and approve manufacturing batch records and related documentation.
• Perform lot disposition and release of raw materials.
• Assist with investigations and deviations as appropriate.
• Maintain organization and control of project documentation.
• Ensure compliance with current Good Documentation Practices.

Skills

Quality assurance

Regulatory knowledge

Communication skills

Attention to detail

Independent work

Education

BS/BA in an applicable scientific field (chemistry/biology/biochemistry)

Tools

Microsoft Word

Excel

Smartsheet

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI, is seeking a Quality Assurance Specialist II to support preclinical, clinical, and commercial drug candidates. You will review manufacturing batch records, analytical data, and reports, helping ensure compliance with cGMP and related quality systems.

The role requires a BS/BA in a scientific field, 3+ years in QA within biotech/pharma, and strong communication skills. Experience with GMP, GCP, GLP, ICH, and FDA guidance is preferred.