Quality Supervisor

Position Summary The Quality Supervisor is responsible for overseeing Quality Control and laboratory functions at Colorcon’s Belen site. This role is responsible for managing the site’s Quality Control team, in addition to the maintenance and operation of laboratory equipment, including calibration. Responsibilities Duties Develop new Quality Control (QC) methods and optimize existing methods to ensure accurate analytical results. Implement required analytical methods from the Development Application department and USP test standards. Responsible for all incoming, in-process, and outgoing quality control, including data integrity validation per ALCOA. Represent the Quality Control (QC) department during internal and external audits. Manage customer and supplier complaints (QNS) and ensure CAPA effectiveness. Monitor and stop production as warranted, based on quality standards and procedures. Maintain archive batch files and retain samples. Provide technical support to production. Translate customer specifications into internal specifications. Responsible for calibration and maintenance of all site measuring and test equipment. Ensure required calibration of laboratory instrumentation is carried out according to schedule. Maintain the Quality module for materials in SAP, including material inspection plans, certificate profiles, and master characteristics. Ensure Quality Control compliance for batch release. Create and maintain all QC documents in the company document management system. Ensure environmental monitoring is performed per operating procedures. Ensure EHS compliance for the QC team. Maintain the non-conformance process and ensure operating instructions are implemented and followed. Manage quality staff (direct reports) to ensure efficient and timely service to internal and external customers. Responsible for the development and training of the Quality Control team. Support the Quality team during the absence of the Quality Manager. Pilot change control and follow up as needed. Liaise with other departments as required. Perform other duties as assigned.