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Quality Management System 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 Specialist to join our team. As a Quality Management System Specialist, you will be responsible for the technical administration of our Quality Management System (QMS) software, MasterControl. This includes providing support to all users from Quality, Production, Regulatory, and other departments to ensure effective utilization of the system.

Key Responsibilities:

  • Administer the QMS system, including training, document control, SOP management, CAPA, deviation, change control, audit management, and integrated business process management.
  • Provide technical support to users, ensuring they are properly trained and utilizing the system effectively.
  • Manage SOPs, batch control, and training to verify users are following manufacturing processes and signing off on proper steps.
  • Collaborate with the Quality team to implement and maintain the QMS system, ensuring compliance with regulatory requirements.
  • Develop and maintain documentation, including procedures, work instructions, and training materials.

Requirements:

  • Bachelor's Degree in a related field or equivalent experience.
  • 3+ years of experience in QMS administration in the medical device or pharmaceutical industry.
  • Extensive experience with QMS software, with MasterControl as a plus.
  • Strong leadership skills, with the ability to manage multiple priorities and meet deadlines.
  • Excellent attention to detail and ability to perform accurate work.

Preferred Qualifications:

  • Knowledge of sterile aseptic filling operations.
  • Experience working in a dynamic, hands-on role in a startup or small company.
  • Contract manufacturing experience working closely with customers and clients.
  • Experience with QMS software, specifically MasterControl.

What We Offer:

  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.

How to Apply:

If you are a motivated and experienced Quality Management System Specialist looking for a new challenge, please submit your application, including your resume and a cover letter, to Management Recruiters of Edison.