Quality Assurance Engineer - Analytical Method Validation

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive salaries

Excellent benefits

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI, seeks a Quality Assurance professional to lead method verification/validation activities supporting pre-clinical, clinical, and commercial programs.

The role focuses on establishing and maintaining GMP-compliant quality systems, reviewing validation documentation, and mentoring QA staff while collaborating with cross-functional teams to ensure data integrity and regulatory readiness.

Qualifications

• Bachelor’s degree or higher in a science field.
• 8+ years’ experience in cGMP manufacturing, focused on method validation.
• Working knowledge of GMP regulations (ICH Q2, ICH Q7, 21 CFR 210/211, EU Annex 11/15, and 21 CFR 11).
• Excellent attention to detail and organizational skills.
• Strong verbal and written communication abilities.
• Proficient in Word and Excel.

Responsibilities

• Serve as QA SME on method validation, review and approve validation strategy.
• Draft and approve procedures for quality systems related to qualification and validation.
• Mentor QA team in quality engineering functions.
• Collaborate with cross-functional teams to review data and vendor data for validation.
• Support deviations, change controls, and CAPAs related to validation activities.
• Support periodic reviews for validated systems/processes and CPV procedures.

Skills

Attention to detail

Organizational skills

Communication skills

Multi-tasking

Interpersonal skills

Education

Bachelor’s degree or higher in science

Tools

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI, seeks a Quality Assurance professional to lead method verification/validation activities supporting pre-clinical, clinical, and commercial programs.

The role focuses on establishing and maintaining GMP-compliant quality systems, reviewing validation documentation, and mentoring QA staff while collaborating with cross-functional teams to ensure data integrity and regulatory readiness.