QA Engineer

• safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures
• provide independent assurance that delivers high quality data and clinical supplies
• Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations
• Coordinate and/or support the preparation of procedures, processes and quality improvements
• Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions
• Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building
• Providing on-the-floor coaching/guidance of operational and technical issues; providing immediate resolution on the shop floor to deviations and potential deviations
• Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times
• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible
• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem-solving and day-to-day operational activities

Senior Specialist, Clinical Supply Quality Assurance

Lead Supplier Quality Engineer

Senior Associate – Quality Assurance and Testing Analyst

Manager, QA External Manufacturing

Principal Penetration Tester