TFL Lead Operator 1st Shift

Lead Operator on primary filling line. Responsibilities include but are not limited to, training other operators, completing and reviewing related TFL paperwork, maintain necessary supply levels of materials needed for TFL operation, assisting with the coordination of cleans. Maintaining certification in the area(s) you are running.  Work with all supervision and employees to ensure that cGMPs, and Praxis’ SOPs, policies and work instructions are being followed. Complete batch related documentation in a careful, legible manner with minimal errors.  Determine batch yield and reconcile all components as part of batch record completion.

• Know and accurately complete all paperwork (ex: batch record, PLCL, CPO, Clean-up, Start-up, Log book, Rate Sheets, Skid Tickets, MFG Board, etc.).
• Review completed batch records for accuracy and completeness, as needed.
• Check all products and components with each job on the line for accuracy and record required product and component information in the batch record.
• Check the quality of the product and call for Quality Assurance when needed.
• Adjust operations as necessary to achieve quality and efficiency goals for the line.
• Perform minor adjustments on machines (i.e. label, and tape changes).
• Challenges vision systems.
• Make sure the line is cleared per the proper line clearance procedure and cleaned between jobs and at the end of the shift.
• Communicate any problems or concerns with the Shift Supervisor.
• Tag and remove skids from the line.
• Have sufficient amount of product and components on the line to allow for a steady flow of work.
• Comply with all safety, quality, and GMP practices.
• Coordinate room cleans with personnel, ensure clean is conducted correctly and timely.
• Assist in the monitoring of acceptable levels of necessary TFL related materials and supplies.
• Assist in ensuring smooth and efficient line changeover, which may occur during the shift, engaging Maintenance when required.
• Ensure maintenance issues are communicated and resolved promptly.
• Maintain First Aid and CPR certifications; assist employees with first aid needs.
• Adherence to all Company policies and procedures.
• Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
• Instills a sense of quality through modeled quality behaviors and mindset.
• Assists with Training and Orientation.
• Elevates complaints and problems, seeks Management assistance.
• Ensure proper PPE’s and Safety procedures are followed.
• Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed.

• High school diploma or equivalent required, Associates Degree or equivalent combination preferred
• 2-4 years similar experience required.
• Lead/Group Leader experience preferred.
• Basic Mechanical and mathematical aptitude required.
• The ability to work independently, without supervision required.
• Ability to organize priorities and workload required.