Description

The position is responsible for leading the operation of equipment and resources used in the manufacturing of Prepared Culture Media plates, bottle and tubes in a cGMP compliant manner.

The shift for this position is: Monday evening - Saturday morning: 10:00 pm - 6:30 am

Job Duties:

• 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.
• AQL inspections, reworks and Material reconciliation that goes along with the batch.
• This individual is expected to have a thorough understanding of all manufacturing activities, and their associated training and documentation requirements. They should display a high level of expertise and leadership in supporting flow of operations within the department.

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 Associates 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.