Senior QA Specialist, Biotech GMP & Vendor Documentation

Arrowhead Pharmaceuticals; Verona (WI); Vor Ort; USD 70.000 - 110.000; Vollzeit

Benefits dieser Stelle

Competitive salaries

Excellent benefit package

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Assurance

GMP regulations

Communication

Document management

Ausbildung

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

Tools

Adobe Acrobat

Microsoft Office

Jobbeschreibung

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.