Manufacturing Specialist Aseptic Training

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As part of the manufacturing team at the PCI-Madison Site, the Aseptic Manufacturing Trainer is identified as a subject matter expert with focused knowledge and skills in procedures, techniques, tools, materials, and equipment. They provide direct support to manufacturing personnel to ensure Good Manufacturing Practices (GMP) and core competencies are met. As an aseptic manufacturing trainer, you will be responsible for training manufacturing personnel and reinforcing proper cGMP behaviors in accordance with our SOP and manufacturing procedures and by applying your aseptic knowledge and prior professional work experience.

The individual serving in this role will be required to maintain their own manufacturing and aseptic qualifications allowing them to be staffed to the production line based on business needs. This individual will be responsible for the daily training of new/tenured personnel. The incumbent will need to maintain and monitor all aspects of the trainee's progression to ensure proper technique and knowledge are being demonstrated to the trainee throughout the entire training process.

This role is a full-time position within manufacturing operations; the incumbent is responsible for training future trainers in the department as well, this will ensure sustainability of the training program.

The individual serving in this role will also provide support on batch record review, deviation investigations, CAPAs, and other manufacturing documentation needs as required.

• Ensure safety of manufacturing area and work practices in accordance with all PCI Health, Safety and Environmental program. Assists in coordinating of manufacturing personnel in the cGMP operations to meet all scheduled manufacturing work
• Act as SME and primary trainer to potential operations trainers
• Ability to effectively train manufacturing associates on the proper manufacturing curriculum, focused on OJT (on-the-job training) and related Standard Operating Procedures (SOP)
• Develops, maintains, and organizes current and accurate manufacturing training material, learning activities, handouts, worksheets, job aids, and class evaluations
• Ensure efficient operation of process floor activities by developing processes, materials, GMP and safety controls
• Guide and train employees to ensure QSR and ISO requirements have been properly implemented and are continually met. Partner with Quality to ensure a cGMP operation
• Assist team in planning and execution of manufacturing instructions in order to perform equipment preparation, compounding, filtration, formulation and fill activities for aseptic and terminally non-aseptic products in accordance with Good Manufacturing Practices (GMP) standard operating procedure, applicable Quality System and Regulatory requirements
• Become a highly visible, hands-on team builder to motivate, coach, support, inspire and retain highly effective teams
• Collaborate with the Operations, Material Management, Engineering, and MTS teams to optimize processes, specifically applying Lean principles if applicable
• Drive efforts to address regulatory compliance issues related to production.
• Work with Manufacturing Supervisors to provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards
• Proactively identifies, assesses, and mitigates operational and organizational risks; elevate key risks and issues to manufacturing senior management and cross-functional support teams
• Ensure manufacturing instruction set and production records reflect practice, are aligned to cGMPs/ISO and corporate standards
• Provide support of batch record review, deviations, and CAPAs to ensure timely completion.
• Assist in the maintenance of department quality metrics to measure, analyze, and improve team…