Formulation Team Lead - Night Shift D - Biofire
Durham, NC
About the Job
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.
Source : Biofire
