GCP Quality Assurance Specialist – Clinical Trials

Arrowhead Pharmaceuticals; Los Angeles (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Pasadena, CA is seeking a Clinical Quality Assurance Specialist to support GCP compliance and QA activities across clinical operations.

You will assist in GCP quality event management, risk-based audits, regulatory inspections, CAPAs, and collaboration with Clinical Operations to ensure data integrity and continuous quality improvement across programs. The role may require travel to Arrowhead locations as needed.

Qualifications

• Bachelor's degree in science required.
• 3 years in a regulated environment with preference to quality assurance, auditing and/or GCP experience.
• 2 years of GCP experience providing Quality and Compliance oversight.
• Strong knowledge of GCP and FDA, European regulations and ICH guidelines.
• Competent with Veeva, Word, PowerPoint and Excel.

Responsibilities

• Develop and maintain quality study risk plans and update in Quality Management System.
• Collect site metrics for audits and analyze trends in findings.
• Support and lead internal audits.
• SOP review.
• Communicate audit results, CAPAs and other quality events for continuous improvement.
• Track deviations, SCARs and CAPAs.

Skills

GCP knowledge

FDA regulations

ICH guidelines

Veeva

MS Office

Audit experience

Quality Assurance

Education

Bachelor's degree in science

Tools

Veeva

MS Word

PowerPoint

Excel

Job description

Arrowhead Pharmaceuticals, Inc. in Pasadena, CA is seeking a Clinical Quality Assurance Specialist to support GCP compliance and QA activities across clinical operations.

You will assist in GCP quality event management, risk-based audits, regulatory inspections, CAPAs, and collaboration with Clinical Operations to ensure data integrity and continuous quality improvement across programs. The role may require travel to Arrowhead locations as needed.