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 and/or process-driven Reagent formulation. The Team Lead position includes all aspects of production work including inspection, maintenance, cleaning, troubleshooting and repair of manufacturing/process equipment. Team Lead assists in the development of employees and drives accountability for team performance metrics and projects. The Team Lead position includes

• All aspects of production/packaging and maintenance work including inspection, maintenance, cleaning, troubleshooting and repair of manufacturing/process equipment

• Assist in the development of employees

• Drive accountability for team performance metrics and projects

• Effectively leading quality initiatives critical to the department’s ability to improve manufacturing processes

• Improve departmental productivity, efficiency, and product quality

• Reduce manufacturing costs/scrap

  Primary Responsibilities:

• Leadership

• Serve a back up to the Supervisor (or higher) when needed

• Develop manufacturing team

• Inspire and motivate manufacturing team to achieve top performance as a team

• Inspire and promote self-growth and internal development within the team

• Assist in management of daily activities i.e; scheduling production activities & Daily shift tie-in meetings

• Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making

• Conduct staff meetings daily or as needed, keeping records/documentation of what is discussed

• Production

• Formulation: Operate and maintain highly automated process batching equipment with HMI/SCADA interfaces used for chemical weighing and reagent formulation in a cGMP compliant manner

• Provide feedback on design and operation of equipment to optimize manufacturing

• Check equipment during production runs for proper performance and assures the equipment is maintaining standard speeds and process times

• Troubleshoot simple to moderate equipment related issues

• Quality

• Right First Time (RFT): minimal deviations and error free performance

• Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner

• Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs

• Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns

• Perform self-audit of rooms and processes

• Train and certify teammates on production processes and procedures

• Documentation / Training

• Utilize SOP and documentation to record data manually or through identified software applications

• Assist in the development, revision of manufacturing procedures and training programs for manufacturing employees.

• Ensure overall team training is maintained current for processes and procedures relevant to all area activities

• Coordinate cross-training among roles to create staffing flexibility and increased depth.

• Safety

• Comply with all safety policies and procedures at all times

• Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.

• Monitor workers on site during production activities to ensure adherences to ethics and safety procedures

• Continuous Improvement

• 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 scrap, increase product quality, decrease operational costs, and improve 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

• 5S: Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements

• Other Duties

• Contribute to team goal development, status tracking and communication by providing feedback to the direct manager for the PMP (Performance Management Program) process

• Work with other departments and assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state

• Partner with maintenance staff to perform routine and preventative maintenance activities to include inspecting, lubricating, adjusting of manufacturing equipment in a timely basis to ensure reliability and minimize the incidence of unplanned downtime to production equipment

• Communicate with Materials Management, Production Operations, and Quality Control on a daily basis to ensure the timely and efficient production of all of our customer requirements

• Perform other duties as assigned by Management

  Education, Skills, & Experience:

• High school diploma/GED with minimum of 3 years in a regulated production/operations environment

• A basic chemistry and lab application experience strongly desired

• Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired.

• Familiarity with measurement scales, mixing, blending, chemical mills and other formulation manufacturing equipment strongly desired.

• Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.

• Knowledge of FDA and/or GMP regulations preferred.

• Mechanical background preferred.