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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/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 Duties:

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

+ + Manufacturing & Packaging: Operate and maintain highly automated bottle handling, filling, vision inspection, conveying, robotic palletizing, autoclaving, and / or labeling equipment in a cGMP compliant manner, using HMI/SCADA interfaces

+

+ + Setup high speed manufacturing equipment, within defined tolerances, to ensure product runs are started on time and within established guidelines

+ + 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 requirement

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

Skills, education and experience:

+ High School Diploma or GED and Minimum of 3 years in a regulated production/operations environment

+ Associates Degree in an applicable or Technical field or Vocational / Technical School preferred

For Formulation: a basic chemistry and lab application experience strongly desired

+ For Manufacturing and Packaging

+ Demonstrated proficiency in the operation of high speed, highly automated, production equipment preferred.

+ For Formulation

+ 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.

+ Ability to rapidly learn new procedures and reduce them to practice.

+ Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.

+ Demonstrated experience of working independently

+ Attention to detail and the ability to accurately interpret technical documentation

+ Excellent communication skills, teamwork orientation

+ Organizational skills, ability to prioritize work