Position Summary

The Team Lead position is responsible for front-line leadership of a team engaged in the operation of high-speed manufacturing/packaging equipment. The Team Lead position includes all aspects of production/packaging and maintenance work including set-up, operation, inspecting, maintenance, cleaning, troubleshooting and repair of manufacturing/process equipment. The Team Lead position develops employees by providing feedback to the direct manager to assist in thorough effective personnel performance management and driving accountability for team performance metrics and projects. The ability to effectively lead quality initiatives is critical to the department’s ability to improve manufacturing processes, increase product quality, improve departmental productivity/efficiency, and above all, reduce manufacturing costs/scrap. Contribute to building a positive work environment.

Primary Duties

• Assist in maintaining an efficient and effective workforce. Maximize equipment and process capabilities. Maintaining the VITEK 2 card manufacturing operation so that it is GMP compliant and meets FDA and ISO requirements. Maximize productivity with a goal of operating the manufacturing equipment to meet and exceed the Operating Equipment Efficiency (OEE) goals determined by World Class Manufacturing standards to support business demands.
• Maintain proficiency to operate high speed manufacturing equipment efficiently and effectively using HMI/SCADA interfaces.
• Maintain signature authority to perform area clear, line clearance and first articles.
• Provide support and training to the production team for advanced troubleshooting of high speed automated equipment.
• Leverage statistical process software to maintain optimal process centering. Check equipment during production runs for proper performance and assures the group is maintaining standard speeds. Recommend changes in equipment that would benefit line performance.
• Assist in creation and implementation of training/development plans for new equipment and assigned teammates. Provide feedback on design and operation of equipment to optimize manufacturing.
• Assist in developing and revising manufacturing procedures and training programs for manufacturing employees.
• Ensure overall team training is maintained current for processes and procedures relevant to all manufacturing/packaging activities and coordinate cross-training among roles to create staffing flexibility and increased depth.
• Assist in assignment of daily activities i.e.; scheduling production activities, breaks, lunches & Daily shift tie-in meetings.
• Provide a level of mechanical, electrical and instrumentation understanding to assist Process Technicians and Maintenance personnel with routine problem solving.
• Ensure the production of high quality products that are made with multiplicity of materials and assembled on a high-speed multifaceted production line. Ensure Quality Assurance is communicated to the team for minimal deviations and error free performance.
• Review documentation to support manufacturing and maintenance history records to ensure adherence to FDA Regulations, GMP, ISO, Department Procedures and Manufacturing Directions. Ensure the most recent information related to manufacturing and maintenance is communicated and/or documented for compliance, history, and reliability.
• Contribute to team goal development, status tracking and communication by providing feedback to the direct manager for the PMP (Performance Management Program) process.
• Contribute to a positive team environment.
• Perform all work in compliance with company quality procedures and standards.
• Inspire and motivate manufacturing team to achieve top performance as a team.
• Inspire and promote self-growth and internal development within the team.
• Lead and promote continuous improvement through team and individual initiatives.
• Identify areas of deficiency and implement practices to improve employee safety and to reduce the cost incurred through excessive scrap, poor workflow/process design and others.
• Serve as a project team member to reduce scrapped lots/materials, increase product quality, decrease operational costs, and increase departmental efficiency/productivity.
• Serve as change agent by driving the required cultural transformation and the adoption of successful process improvement practices. Diagnoses barriers to project success and facilitates resolution.
• Provide assistance with the creation, review and revision of instructions and SOPs necessary for the Manufacture of VITEK 2 card products.
• Assist with Manufacturing investigations, CAPA actions and other process equipment related quality concerns.
• Utilize a variety of software systems to support daily work activities (i.e. MES, TrackWise, LiveLink/DocLink, SAP, Corhus, Compliance Wire etc.).
• Communicate information effectively and succinctly (facts, ideas, messages) and in an organized manner real-time.
• Perform other duties as assigned.

Qualifications

• High School Diploma, GED or equivalent required
• 5+ Years FDA/GMP and Manufacturing Experience required

Knowledge, Skills, and Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Effective verbal communication skills
• Written Communications - including the ability to communicate technical data in written form
• Communicates instructions clearly and effectively
• Inspire and energize individuals to achieve their best performance
• Informing others by sharing clear, timely information to ensure alignment.
• Basic: demonstrates fundamental awareness and can perform routine tasks with guidance

Supervisory Responsibilities

• Direct supervision of approximately 6–10 employees; no indirect supervision.
• Decisions with short-term impact require little-to-no supervisory review.
• Decisions with long-term impact require supervisory review/approval.

Supplemental Data

• Oversee Manufacturing daily activities and/or performing the batch record review to ensure adherence to the appropriate departmental procedures and batch record release activities.
• Perform line clearance, area clear and documentation verifications.
• Ensure that all processes and procedures that are performed are documented in a timely manner in accordance with company and regulatory regulations.
• Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all applicable regulatory policies/regulations.

Working Conditions

• Ability to remain in stationary position, either sitting or standing, for prolonged periods
• Ability to ascend/descend stairs, ladders, ramps, and the like
• Ability to wear PPE correctly most of the day
• Ability to operate heavy machinery
• Ability to adjust or move objects up to 50 pounds in all directions