- Coordinates the Production Schedule and daily Production Floor activities in compliance with cGMPs and ISO requirements.
- Ensures work order start and closure are completed on time with minimal changeover times.
- Coordinates efforts of Manufacturing Services Associates to resolve Production Floor issues.
- Serves as departmental representative with other departments for problem resolution and production reporting.
- Generates department metrics reflecting weekly and monthly performance.
- Ensures cross-training of employees are regularly implemented.
- Identifies hazards on a regular basis for correction.
- Participate in productivity projects.
- Supports the Area Manufacturing Supervisor by completing assigned tasks.
- High School Diploma or equivalent, College degree preferred. Manufacturing Services Associate for one year or equivalent experience.
- Knowledge of compliance FDA/Quality System Regulations is required.
- Knowledge of compliance with company QS procedures required.
The Lead makes decisions on the Production Floor to ensure the manufacture of quality products to the customer in accordance with manufacturing SOPs and written work instructions, and makes decisions on behalf of the Area Supervisor on designated projects, methods and procedures.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to stand; walk; use hands to handle or feel objects, tools, or controls.
- The employee frequently is required to reach with hands and arms and stoop, kneel, crouch, or crawl.
- The employee is occasionally required to sit.
- The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Vision abilities required by this job include close vision, distance vision, color vision, and the ability to adjust focus.
- While performing the duties of this job, the employee is frequently exposed to various temperature conditions and the company provides the necessary PPE assigned to that task.
- The employee will be required to work near or around moving mechanical parts. PPE assessments, SOP and JSA serve to guide in providing the necessary safety protection guidelines for employees that may exposed to hazardous chemicals.
- The noise levels in the work environment do not exceed the OSHA permissible limits however ear protection is available upon request.
- Ability to work in room temperature to – 20 ºC.
This position has not been approved for relocation benefits.
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