ROLE SUMMARY 

This position is responsible for leading and organizing the shop floor to be align with daily operational needs.  Clearly communicates supervisor's instructions and production schedules to employees in accomplishing a variety of tasks, in meeting quality, accountability, security, productivity and safety requirements per SOP's, batch records, CGMP's, and Plant Procedures.  Reports quality, security, accountability and efficiency discrepancies and production progress to supervisor. Maintain aseptic coaching techniques in compliance with all aseptic behaviors, SOPs, and Pfizer Site Policies. Observe aseptic processing areas to continuously improve aseptic behaviors and techniques in the execution of production related activities.  This individual will coach and provide feedback to aseptic personnel, aseptic quality and aseptic management to improve manufacturing processes.  Perform work in strict compliance with manufacturing standards and all regulatory requirements, as well as strict adherence to safe work practices. 

ROLE RESPONSIBILITIES  

• Functions as the leader for the shop floor and coordinates daily activities to meet production schedule attainment.  

• Assists, trains and performs line duties as required in meeting production requirements.   

• Promotes teamwork, a positive work environment and an atmosphere that enhances continuous improvement in efficiencies, material variances and product quality.  

• Under supervisor guidance, monitors training requirements and recommends training to assure employees perform jobs correctly.   

• Follow all SOPs, cGMPs, batch records, TCPs, BOMs and POPs and remain current with all training requirements. 

• Demonstrate and promote a “Right the First Time” culture, while operating in a safe manner, elevating all safety issues and concerns appropriately and in a timely manner. 

• If supervisor is not available, serves as point of contact for questions pertaining to line runnability, production schedule and/or batch documentation.     

• Able to take on additional responsibilities such as project and/or process improvement lead initiatives deemed appropriate by supervision. 

• Serve as a mentor, and trainer for full-time and contracting Filling Operators in the area. 

• Ensure batch related documentation and inventory transaction consumption are complete and accurate. 

• Responsible for ensuring all team members are always acting with appropriate Aseptic Behaviors while performing aseptic operations (i.e. filling) 

• Aseptic Qualifications completed and maintained 

• Observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite and implement and identify needed improvements. 

• Provide immediate feedback during routine observation in an effort to develop colleague capabilities. 

• Evaluate aseptic processes during validation smoke studies 

• Oversees documentation within area of responsibilities following ALCOA principles.  

• Responsible for escalating personnel/behavior related issues as well as aseptic behavioral issues to supervision. 

• Maintain aseptic coaching techniques in compliance with all aseptic behaviors, SOPs, and Pfizer Site Policies. 

• Performs other duties as assigned by supervisor. 

• Ensures team members are always exhibiting appropriate Aseptic Behaviors while performing aseptic operations (i.e. filling) 

• Understands Core Processes (Filling) and able to perform core process tasks as needed depending on shop floor demands 

• Participates and serves as SME in support of area or regulatory audits (GMP/Maintain Audit readiness)  

• Ensure daily, weekly, & four-week cleanings are performed per applicable procedures 

• Supports cleaning and start-up activities as it pertains to shutdown.   

QUALIFICATIONS  

• Must have a high school diploma or general education degree (GED) equivalent. 

• 3+ years of production, manufacturing, or operations related experience. 

• Completed or willing to complete Certified Trainer course. 

• Experience interacting with regulatory agencies is strongly preferred.  

• Effective Leadership Skills – Work with integrity, inspire others, and is accountable.    

• Must have basic math and reading comprehension skills; perform unskilled work and follow detailed instructions 

• Must be able to gown aseptically and retain certification.  

• Under t