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