- 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.
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