Shire Jobs

Job Title: Quality Assurance (QA) Supply Chain Specialist Reports to: Quality Management System (QMS) Manager Classification: Full Time, Exempt Work Location: Onsite - Rochester, MN POSITION SUMMARY: The Quality Assurance (QA) Supply Chain Specialist position is responsible for oversight, administration, and execution of the Supplier Quality Program in compliance with applicable regulations. This position will require participation in the internal auditing program and supporting site regulatory inspections and customer audits. PRINCIPAL RESPONSIBILITIES: Primary supplier quality liaison for clients and internal customers. Conduct risk-based supplier audits, evaluations, and assessments. Issue supplier complaints and drive for resolution and corrective action. Develop and maintain Supplier Quality Agreements and questionnaires. Perform Quality review and approval of supplier-affected Change Controls. Manages onboarding of new suppliers and materials. Manages the site approved supplier list. Perform statistical evaluations to identify trends and report on Supplier Quality metrics (scorecards). Participate and present supplier quality data in Management Review. Determine next steps for suppliers not meeting supplier scorecard metrics. Conduct internal quality audits and develop and assess subsequent corrective action recommendations. Provide support for FDA or other regulatory inspections and customer audits. Provide leadership and coordination on assigned projects. Ensure a safe and quality working environment through training, awareness and compliance to regulatory guidelines and procedures. Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.). Performs other duties as assigned.