The Quality Engineer is responsible for providing quality oversight for the introduction of new products and production equipment to ensure SOP/GMP compliance at the Cleveland Manufacturing Facility. Works closely with MS&T, Validation, Engineering and Operations to provide compliant solutions for commissioning, qualification, and validation activities. Works with Production personnel to complete on-the-floor, in process batch record review, resolve all batch related issues or escalate to the Quality Assurance Manager as appropriate, and ensure good documentation practices are being followed. Recommends corrective actions or process improvements that will eliminate the potential for manufacturing deviations. Key Responsibilities The primary focus of the Quality Engineer covers: Technical Transfers of New Products; Validation and Commissioning/Qualification of Facilities, Equipment and Processes; On Floor oversight in Manufacturing and Packaging areas; Incoming Material...