Manufacturing Team Lead

BioFire Diagnostics, LLC. • Durham, NC • 4h ago

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

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