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Responsible for processing vendor invoices to ensure timely payment to vendors. Responsible for ensuring compliance with company policy regarding initiation and approval of payments including matching invoices with appropriate supporting documents.
Part of the Manufacturing Technical Services (MTS) group, the process engineer at Noven ensures day to day operations are controlled by assuring proper control strategies such as adequate GMP documentation to minimize human error and maintaining process performance. The process engineer at Noven Pharmaceuticals will ensure all equipment, facilities, and utilities used to manufacture products meets its design requirements and is qualified for its intended purpose using a risk based approach. This entails oversight of equipment design including URS, FAT, and SAT, and the design, execution, and reporting of equipment installation, operational and performance qualification protocols. Ensures commercial product material and component changes are qualified using a risk based approach. Maintain processes to manufacture a robust quality product that meets customer and regulatory requirements. Identifies and implements opportunities to improve process efficiency and reduce cost while maintaining product quality. Resolution of process related investigations. Performs root cause and statistical data analysis to recommend specific investigation points of interest and implements teams and/or designs experiments that allow resolution of process anomalies. Able to connect output data to potential input shifts from raw materials or processes. Works closely with Engineering, Operations and Quality Groups to control process variations resulting from equipment design or performance variation. Oversees design of experiment (DOE) related to product or process variation in mature commercial products. Interacts closely with QE to ensure mature product continued process verification. Interacts closely with other members of MTS group for product related issues and to ensure an adequate transfer of knowledge to successful commercial manufacture of quality product throughout the lifecycle.
PLEASE NOTE: THIS IS A TEMPORARY ASSIGNMENT
Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.
Provide technical support to manufacturing, engineering and other departments / team by ensuring maximum equipment uptime, and addressing technical challenges, with a focus in delivering good setups. When not supporting manufacturing, technician shall perform scheduled and on-demand PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and effectively documents simple technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components.
PLEASE NOTE: THIS IS A TEMPORARY POSITIONThe production operator performs all the general duties and operations to manufacture the product. An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. The operator will complete the necessary documentation and records to maintain quality control.
Performs professional, technical laboratory functions with versatile capabilities throughout the laboratory. Serves as a technical resource in the laboratory providing scientific expertise and problem solving skills.
Perform all activities related to investigation of customer complaints, process return samples for credit and reconcile call center complaints. Ensure on-time closure of complaint records and tasks associated with data requests from other departments. Identify critical complaints and prioritize these investigations to meet reporting requirements. Monitor complaint activity for trends and conduct trend investigations as appropriate. Generate and report metrics for monthly Council meetings, quarterly status meetings and annual product reviews. Participate and support in all team activities and projects as assigned.