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Quality Assurance Specialist

2 months ago

Lawrence, Kansas, United States Management Recruiters of Edison Full time

Job Summary:

The Management Recruiters of Edison is seeking a highly skilled Quality Management System (QMS) Administrator to join our team. As a QMS Administrator, you will be responsible for the technical administration of our quality management system, MasterControl, and provide support to all users from Quality, Production, Regulatory, and other departments.

Key Responsibilities:

  • Administer the QMS system, ensuring seamless integration of quality-related functions, including Training, Document Control, SOP Management, CAPA, Deviation, Change Control, Audit management, and integrated business process management.
  • Provide technical support to users, ensuring they utilize the system effectively.
  • Manage SOPs, verifying users, and signing off on proper steps for processes.
  • Implement Batch Control to verify operators follow manufacturing processes with proper signoffs.
  • Develop and maintain training programs to ensure all employees are properly trained and tracking progress.

Requirements:

  • Bachelor's Degree or related field.
  • 3+ years of QMS experience in the Medical Device or Pharma Industry.
  • Flexibility and ability to manage multiple and competing priorities.
  • Ability to multi-task with strong sense of urgency; ability to meet deadlines.
  • Some leadership skills to take charge and fully launch the QMS implementation.
  • Excellent attention to detail and capable of performing dependable, accurate work.

Preferred Qualifications:

  • Knowledge of Sterile Aseptic Filling Operations.
  • Startup or Small company experience working in a dynamic and hands-on role.
  • Contract Manufacturing experience working closely with customers and clients.
  • Work experience with QMS – MasterControl as used by the Company.

Language: English (en-US)