Formulation Team Lead - Night Shift D

Location: Durham, NC, United States

Position Type: Unfixed Term

Job Function: Manufacturing

• 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

• 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

• 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.