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
