Arrowhead Pharmaceuticals

Specialist III, Supplier Quality

Verona, Wisconsin, United States · Mid

Sponsorship not specified$85k-$95kDetected 18 days ago

FDA RegulatoryResearchAnimal StudiesCommunicationMicrosoft Office

About the role

The purpose of this position is to provide quality assurance support for the Supplier Quality Management program in all aspects of qualification, monitoring, and continuous improvement of suppliers, contract manufacturers (CMOs), contract testing laboratories, and material suppliers.

Support supplier qualification, requalification, and ongoing monitoring activities for raw material suppliers, CMOs, contract laboratories, packaging vendors, and service providers.
Collaborate with stakeholders and suppliers, as needed, on quality events and non-conformances and issue supplier corrective action requests (SCARs), as outlined in the applicable quality agreements.
Perform quality agreement lifecycle management, including but not limited to, drafting, editing, reviewing, approving, and ensuring compliance with periodic review cycles.
Identify recurring issues and support continuous improvement initiatives.
Assist with preparation, update, review, and routing of Arrowhead procedural documents.
This person will be expected to interact with internal departments as well as multiple contract organizations to support ongoing pre-clinical and clinical development as well as commercial programs at Arrowhead Pharmaceuticals, Inc.

Minimum of 5 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization with an emphasis on Supplier Quality.
Prior experience with use of an electronic document management system in a regulated environment.
Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and Smartsheet.
Ability to consistently communicate with external parties in a professional manner.
Ability to follow company procedures, work instructions, and policies.
Candidates must have current, valid authorization to work in the country where this role is located.

Prior experience with use of an electronic document management system in a regulated environment.
Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and Smartsheet.
Excellent interpersonal, verbal, and written communication skills.
Ability to consistently communicate with external parties in a professional manner.
Ability to follow company procedures, work instructions, and policies.
Excellent attention to detail and organizational skills.

This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.