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Signature IT World Inc

Process Quality Engineer

Signature IT World Inc, New York, New York, United States

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Job Title – Quality Process Engineer Location – Sanford, Maine

Industry: Consumer Products / Cosmetics Job Category: Manufacturing – Quality

Job Description: The Quality Engineer provides a critical link between the Innovation team including Implementation and Support (I&S), Engineering (PD&I), Category Technical Managers, Plant Operations, and Quality. Qualifications: Bachelor’s degree in chemical / mechanical engineering, Chemistry or related science/engineering discipline. 2+ years of experience in manufacturing, a quality role or equivalent. A strong background in quality systems, validation, understanding of cGMP and 21 CFR 210 & 211, and experience in working in a regulated industry (i.e. FDA) Working knowledge of SAP, validation software (KNEAT), InBatch systems. Responsibilities: Provide daily support to the plant to address quality issues and continuous improvement initiatives by spending time in the production area and participating in the site Standard Interface effectively with key business partners including Operations, Technology, Business Unit, Procurement, and Vendors to drive Company results. Process Validation & Control: Oversees the validation program, including C&S, conducts risk analysis, maintains and updates, validation master plan, develops validation protocols for PQ, supports IQ/OQ in conjunction with the engineering team.