Line Lead

Under the direct supervision of Production Supervisor, the Line  Lead is responsible for monitoring and/or performing operational tasks of assigned line, while ensuring quality finished goods, to meet production schedules.  

• Completes all cGMP, end-of-shift inspections, and line clearance changeover forms in a timely, correct, and consistent manner.
• Meets production as defined by Ship Rate due date and/or quantity per Work Order. During line production, reviews and closes work orders. 
• Assists Packaging Material Coordinators in closing work orders. Immediately informs supervisor of all employee safety, cGMP, and product safety hazards and concerns.
• Directly communicates and seeks guidance from QA staff within the Packaging room.  Directly communicates mechanical issues to Maintenance Technicians and Supervisor. 
• Initiates and completes Reliability Paperwork.
• Coordinates and resolves with support staff and supervisor’s production and maintenance downtime issues. Does not allow and reports cGMP maintenance violations such as tape to hold equipment in place. 
• Shuts line down in the event of critical quality or safety issues. Immediately informs supervisor and does not bypass or override safety functions and guards.  Recognizes and corrects bulk and components errors on Pick List and Work Orders.  Informs supervisors of errors.
• Coordinates line rework efforts and reports waste to supervisors as directed.
• Ensure that line is operational and perform first piece inspection.
• Perform safety inspection of personnel and equipment.
• At the end of shift make sure all products have been run or covered up. Turn off all working equipment.  Ensure that production sheets or reliability paperwork has been completed.
• Monitor line to ensure all housekeeping duties are completed by line personnel.
• Perform proper line clearance. Verify all components for next run.  Verify correct finished goods count from each setup.  Setup labeler and printer to include lot number and expiration date.  Complete work order from previous run. 

• High School diploma. 
• Ensure job specific safety procedures are established and followed
• Know and understand the cGMP and other regulatory compliance
• Complete all necessary paperwork and proper documentation
• Accumulate all rejects and place into the appropriate containers for proper disposal or rework process
• Ensure proper recording and usage of batch records per established processes
• Ensure that correct raw material and lot numbers are being processed
• Ensure proper labeling of finished product while completing all necessary paperwork / documentation as required
• Follow batch record instructions and maintain accurate and legible production records
• Maintain clean work environment at all times, including and not limited to hygiene practices
• Adherence to the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs) in effect assuring the quality and quantity of product produced is required
• Proven leadership skills including the ability to coach, assess, evaluate, develop, motivate, and empower others
• Maintain awareness and enforcement of health and safety practices and activities
• Be involved in the development, implementation, and updating of health and safety plans and procedures
• Actively participate in health and safety training programs and demonstrate competency based on training received
• Make safety a priority in daily operations by:
  • Actively participating in health and safety activities,
  • Ensuring compliance with regulatory requirements,
  • Ensuring adequate resources are provided, and
  • Providing suggestions for improvement to the health and safety program.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job.  This job description reflects management’s assignment of essential job functions, which are not intended to be an exhaustive list of all responsibilities, duties and skills required.