Formulation Team Lead - Night Shift D
Location: Durham, NC, United States
Position Type: Unfixed Term
Job Function: Manufacturing
A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture.
Description
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.
- 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
- 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.
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