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Fagron Sterile Services Compliance Quality Assurance Assistant in Wichita, Kansas

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13045452

The Compliance QA Assistant supports the Compliance QA Specialist in activities related to Quality Management System (QMS) oversight, audit, and inspection follow up (CAPA) and will support readiness activities.

Role Responsibilities:

  • Assists in projects that impact the QMS. Report on progress against schedules, milestones and project goals. Notify Specialist on project resource needs and availability, identify and report gaps or project constraints.
  • Support all regulatory and customer quality audits.
  • Gather, organize & present data to assist in the development of solutions and new processes.
  • Assist and execute continuous improvement projects.
  • Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
  • Identify compliance issues that require follow-up or investigation.
  • Assist in internal investigations of compliance issues.
  • Maintain documentation of compliance activities, such as investigation outcomes.
  • Track compliance issues within all departments and ensure completion within defined timelines.
  • Disseminate written policies and procedures related to compliance activities.
  • Provide assistance in internal or external compliance reviews.
  • Prepare management reports regarding compliance operations and progress.
  • Monitor/Track compliance systems to ensure their effectiveness.
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