Senior QA Specialist, Biotech GMP & Vendor Documentation

Arrowhead Pharmaceuticals; Verona (WI); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive salaries

Excellent benefit package

Job summary

A biopharmaceutical company in Verona, Wisconsin is seeking a Quality Assurance professional to provide support for development and clinical programs. The ideal candidate will have at least 5 years of experience in a GMP-regulated environment and hold a BS/BA in a scientific field. Responsibilities include reviewing vendor documentation, collaborating with internal departments, and ensuring compliance with quality standards. Excellent communication skills are essential as you will work closely with multiple organizations to maintain quality assurance in the clinical pipeline.

Qualifications

• 5 years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical manufacturing environment.
• Working knowledge of drug GMP regulations and ICH/FDA guidance documents.
• Ability to manage priorities in a fast-paced environment with minimal supervision.

Responsibilities

• Provide quality assurance support for development, clinical, and commercial programs.
• Review and approve vendor-generated documentation.
• Collaborate with vendors on quality events and non-conformances.

Skills

Quality Assurance

GMP regulations

Communication

Document management

Education

BS/BA in Chemistry, Biology, Biochemistry, or related field

Tools

Adobe Acrobat

Microsoft Office

Job description

A biopharmaceutical company in Verona, Wisconsin is seeking a Quality Assurance professional to provide support for development and clinical programs. The ideal candidate will have at least 5 years of experience in a GMP-regulated environment and hold a BS/BA in a scientific field. Responsibilities include reviewing vendor documentation, collaborating with internal departments, and ensuring compliance with quality standards. Excellent communication skills are essential as you will work closely with multiple organizations to maintain quality assurance in the clinical pipeline.