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This position supports Supplier Quality Assurance with activities related to supplier qualification and regulatory compliance. Responsibilities include supplier intake, supplier records management, and supplier audit support. The Supplier Qualification Specialist I will collaborate with Arrowhead business teams, the Supplier Quality team, and internal and external auditors.
Job Responsibility:
Manage initial intake of new regulated suppliers from the business teams
Conduct or assist with supplier risk assessments
Coordinate with internal and external auditors performing supplier audits
Maintain supplier, audit, and qualification records within Veeva
Support Lead Auditors by tracking timelines and preparing required documentation
Maintain supplier licenses, certifications, and related compliance documentation within Veeva
Generate and distribute supplier metrics to QA groups and business stakeholders
Support Arrowhead audits and inspections
Assist with preparation, update, review, and routing of Arrowhead procedural documents
Support eQMS and other system implementations
Perform additional QA duties as needed
Requirements:
Associate’s degree, with BS/BA preferred
1+ year of quality assurance experience
Ability to follow company procedures, work instructions, and policies
Competent knowledge of and ability to use Microsoft Word, Outlook, PowerPoint and Excel
Excellent attention to detail and organizational skills
Ability to multi-task and prioritize work with minimal supervision
Excellent interpersonal, verbal, and written communication skills
Nice to have:
Experience working in biotech or pharmaceutical development, manufacturing, or contract manufacturing organizations
Working knowledge of GMP, GCP, and/or GLP regulations
Prior experience with use of an electronic document management system in a regulated environment
What we offer:
competitive salaries and an excellent benefit package