Specialist II, Supplier Quality

• Support supplier qualification, requalification, and ongoing monitoring activities for raw material suppliers, CMOs, contract laboratories, packaging vendors, and service providers
• Assist with supplier risk assessments and ensure documentation is current and compliant
• Collaborate with stakeholders and suppliers, as needed, on quality events and non-conformances and issue supplier corrective action requests, as outlined in the applicable quality agreements
• Assist with maintenance of approved supplier lists and supplier quality records
• Review and assess supplier change notifications for quality and regulatory impact
• Ensure timely and accurate documentation within the Quality Management System (QMS)
• Track and trend supplier performance metrics (e.g., deviations, on-time CAPA closure, audit findings)
• Identify recurring issues and support continuous improvement initiatives
• Assist with preparation, update, review, and routing of Arrowhead procedural documents
• Assist with other QA duties as needed

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred
• 3 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization with an emphasis on Supplier Quality
• Working knowledge of 21 CFR Parts 210/211, ICH Q7, and applicable global regulatory expectations (e.g., FDA, EMA, Health Canada), along with familiarity with relevant regulatory guidance documents

• 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
• Ability to work independently with minimal supervision as well as manage priorities within a face-paced environment

competitive salaries and an excellent benefit package