Quality Management System Specialist

Contractor, Full Time
CA, San Diego
Posted 3 years ago

Job Description:

  • Support development, implementation and management of Quality Management System (QMS) and related
  • processes to ensure adherence to regulatory and Client requirements.
  • Collaborate with Global Quality Organizations to identify and implement system enhancements.
  • Participate in testing and verification of new and revised system functionality/enhancements.
  • Enter and update system list of values timely, as needed.
  • Support testing and training activities as needed for system implementations and or enhancements.
  • Work cross-functionally to support the creation and revision of policies and procedures in support of Client Quality Systems.
  • Manage user change requests and change process.
  • Gather user requirements and work with technical personnel to define the appropriate configuration for IT Systems to meet defined business requirement.
  • Consult with management and business process owners to ensure QMS system is aligned with user requirements
  • Create reports and metrics for users.
  • Provide regular updates on project progress and escalate challenges as needed.
  • Train end users on the use of new and updated Quality business process, system, policies and procedures.
  • Other duties as assigned

Other Qualifications:

  • Understanding of Quality best practices, including familiarity with Quality Systems Regulations, GxPs, and applicable ISO Standards
  • Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs).
  • Excellent attention to details
  • Ability to effectively manage time and progress tasks to meet timeline in a fast pace/dynamic environment
  • Effective oral and written communication skills
  • Experienced working cross-department with Quality, IT, Clinical, Regulatory and Development.
  • Working knowledge of business process and process improvement
  • Experienced interfacing with external software vendors.
  • Experienced in managing projects towards process improvements.


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