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Senior Supplier Quality Systems EngineerSt Louis, MO
The Senior Supplier Quality Systems Engineer position is responsible for oversight, administration, and execution of the Supplier Quality Program in compliance with applicable regulations. The position is responsible for Supplier Management, including supplier audits, assessments, Quality Agreements, and corrective actions. The position will require participation in the internal auditing program and supporting site regulatory inspections and customer audits.
• Manage the Supplier Quality Program in compliance with applicable regulations by working with suppliers to maintain a compliant status.
• Conduct supplier audits, evaluations, and assessments
• Issue supplier complaints and drive for resolution and corrective action.
• Develop and maintain Supplier Quality Agreements
• Perform Quality review and approval of Change Controls.
• Perform statistical evaluations to identify trends and report on Supplier Quality 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.
• Bachelor of Science degree in Life Sciences or Engineering required.
• Minimum of 5-8 years of Quality experience in a finished pharmaceutical manufacturing environment with a strong understanding of and exposure to applicable quality systems.
• Minimum of 2-3 years of experience in Supplier Quality Management and supplier auditing.
• Minimum of 2-3 years of experience in supporting on-site regulatory inspections.
• Must have working knowledge in Supplier Quality Management, Supplier Auditing, Supplier Assessment, Supplier Quality Agreements, and Corrective Action.
• Must have a working knowledge of cGMP guidelines and their application in a controlled aseptic environment.