Job Information
BioFire Diagnostics, LLC. Production Team Lead 3rd Shift in Lombard, Illinois
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.