+ The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting, and cleaning of equipment used throughout the Prepared Culture Media Packaging processes. + Additionally, this individual will be responsible for preparation, distribution, reviews, of batch records and other documentation required for routine production. Production + Lead shift interval meetings and communicate daily goals and department performance with team. + Track production progress to ensure adherence to timelines and timely interventions for issues. + Perform operator duties on the production floor as needed. + Develop work rotation schedules based on production needs. + Plan and coordinate equipment and component preparation tasks in to meet batch processing timelines. + Perform routine reviews of Batch Records and coordinate completion of corrections to ensure adherence to batch quality requirements. + Proficiently uses Enterprise Resource Planning (ERP) systems to perform functions and material transactions for routine production. + Efficiently coordinate staging, stacking, movement, loading and unloading of production supplies in the appropriate areas. + Handle hazardous and non-hazardous raw materials to move them through the process flows in compliance with outlined procedures and safety standards. + Perform necessary calibrations and verifications of manufacturing equipment. + Execute production activities per approved Manufacturing Directions while maintaining compliance with all job-related SOPs. + Perform ancillary cleaning and sanitization activities of production equipment and areas. + Troubleshoot simple and moderate equipment issues with timely intervention to minimize delays and losses. Communicate appropriately with maintenance and area leads to tackle advanced issues. + Maintain and update daily shift reports to communicate plant performance metrics. + May need to prepare and distribute, Manufacturing Batch Records as needed. Quality + Ensure that all batch documentation is completed in an accurate, thorough, and timely manner and in accordance with Good Documentation Practices. + Perform and direct in-process and AQL inspections to meet batch quality requirements. + Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product. + Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns. + Execute the 5S responsibilities specified for Production Team Lead. + Understand and follow aseptic practices to ensure safety and quality of the products. Safety + Comply with all OSHA and plant specific safety policies and procedures at all times, inform management of any safety hazards, and attend all required safety training. + Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties. Other Duties + Collect accurate data for reports, charts and KPI's and interpret the data to identify problems and proceed with proper decision making. + Participate in Continuous improvement management and execution of SIC meetings and other Continuous Improvement initiatives. + Accurately interpret technical documentation with a high attention to detail. + Assist with executing validation protocols associated with packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state. + Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient execution of production needs. + Perform training and coaching of new team members on production activities. + Perform other duties as assigned by Management. STUDIES High School Diploma or GED Experience Minimum of 9 years in a regulated production/operations environment or associate's degree and 3-5 years in a regulated production/operations environment. Skills + Demonstrated proficiency in the operation of high speed, highly automated, aseptic filling equipment and packaging machines preferred. + Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.). + Knowledge of FDA and/or cGMP regulations within production environment. + Experience working in document management systems such as Livelink. + Experience performing function in ERP systems such as SAP. + Uses excel macros, MS Teams, etc. for project management and tracking. + Basic mechanical and tool handling knowledge and ability to perform hands on troubleshooting. + Ability to rapidly learn new procedures and reduce them to practice. + Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 90-day period of working with a trainer.