What You Will Do

• Ensure compliance with Eagle policies and Standard Operating Procedures (SOPs) and Quality Management System
• Ensures ISO 17025, cGMPs, cGLPs, USP guidelines are interpreted and followed throughout the Eagle
• Write, review, and approve SOPs, test methods, laboratory reports, laboratory logs/worksheets, work instructions, forms, deviations, CAPA’s, change controls, and other relevant GMP records for compliance
• Review laboratory test reports, environmental monitoring, and quality control data
• Support and conduct internal audits of quality documentation and system, and perform daily walk through audits to ensure compliance of all departments
• Review root cause analysis and implementation of corrective action for process related concerns
• Create audit finding reports and determine proper corrective and preventive actions
• Assist with creating and maintaining company quality documentation, such as quality manuals and quality procedures
• Manage auditing and storage of quality documentation and quarantined items
• Responsible for the preparation of training materials for all departments
• Customer interface in Customer Outreach Program at Eagle