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Clean Room Supervisor

Total Plastic Solutions
Lynchburg, VA Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/12/2025

Job Description

Job Description

Salary : $45,000

Total Plastic Solutions is hiring a Clean Room Supervisor. The Clean Room Supervisor works a designated shift and has authority over the Clean Room employees and their day-to-day performance. The Clean Room Supervisor is to ensure maximum productivity from the employees they supervise / lead. The Clean Room Supervisor is responsible for working with and developing employees on their designated shift, this includes training, planning and implementing improvements to the specific shift to ensure current procedures and manufacturing processes are being followed. Employees on their designated shift are to comply to TPS policies, SOPs, cGMP, ISO 9001, ISO 13485, ISO 14001 and AS9100 criteria. This Supervisor will have a focus on ensuring their employees understand and adhere to requirements of CGMP and ISO 13485 standards.

Benefits

  • Medical
  • Dental
  • Vision
  • 401K with company match
  • Paid holidays
  • Vacation time

Responsibilities

  • 1. Ensure Operators on designated shift review and sign off on Operator Instructions daily for each task as to understand all the requirements before starting a job during manufacturing.
  • 2. Communicates with other Shift Supervisors, Quality Manager, Production Managers, Senior Process Engineers, Process Engineers Jr. Processors and Quality Leaders for overall quality.
  • 3. Review Department schedule for their designated shift, identifying needed inventory, and preparing the designated shift for daily objectives.
  • 4. Provide training for Medical Operators on designated shift through written documentation and / or by direct example.
  • 5. Train Medical Operators on designated shift in the use and duties of IQMS and daily production responsibilities.
  • 6. Work closely with Customer Response Specialist / Planner, Quality Leaders and Production Managers to ensure that customer needs are met and exceed their expectations.
  • 7. Be aware of the daily reports, customer complaints, returns or internal part failures and share all information with production and quality teams.
  • 8. Team support and participation.
  • 9. Make sure all work is being done correctly instructing with proper tools (verbal, written, or corrective methods), to mentor the required response for company goals and guidelines to be followed for written manufacturing responsibilities.
  • 10. Monitor Inventory Technicians and Medical Operators on designated shift, develop methods to improve overall production performance, reduce setup times and improve efficiency.
  • 11. Assign Medical Operators on designated shift according to manufacturing priorities.
  • 12. Achieving performance goals (KPI's), maintain and audit 5S standards throughout the Clean Room for designated shift.
  • 13. Provide daily Clean Room production reports (end of shift, for designated shift) to the leadership team.
  • 14. Enforce Company policies and procedures through disciplinary actions as needed.
  • 15. Understand and apply ISO 13485 Clauses( 4.2.4, 4.2.5, 5.3, 7.6, 8.2.4, 8.2.5, 8.2.6, 8.3, 8.5.1, 8.5.2, 8.5.3) to applicable role responsibilities.
  • 16. Understand and apply AS9100 Clauses to applicable role responsibilities
  • 17. Understand and apply ISO 14001 Clauses to applicable role responsibilities
  • 18. Follow requirements of ISO standards to maintain and improve the Quality Management System
  • Requirements

  • A minimum of two years supervisory / management experience
  • Basic knowledge of quality principals
  • Understanding of measuring equipment
  • Preferred experience with CGMP / ISO 13485 standard requirements or understanding of requirements
  • If you feel that you meet the requirements and that this job is the right fit for you, Apply today!

    Job Type : Full-time

    Pay : From $45,000.00 per year

    Benefits :
  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance
  • Schedule :

  • Evening shift
  • Night shift
  • Education :

  • High school or equivalent (Required)
  • Experience :

  • Supervising : 2 years (Required)
  • CGMP : 1 year (Required)
  • Shift availability :

  • Night Shift (Required)
  • Overnight Shift (Required)
  • Work Location : In person

    Salary : $45,000

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