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Fagron Sterile Services Environmental Controls Analyst in Wichita, Kansas

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13549101

An Environmental Control Analyst is responsible for ensuring that Environmental Monitoring adheres to regulations, standards, and internal policies. The role typically involves reviewing and analyzing environmental data, ensuring compliance with SOP standards, and potential process improvement initiatives.

Key Responsibilities

Review Environmental Monitoring Data:

  • Complete review of environmental monitoring data to ensure alignment with Good Documentation Practices. Will include, but not limited to, review of electronic systems, paper-based systems, and logbooks.
  • Responsible for ensuring paper-based processes used for environmental monitoring data is documented and retained appropriately.
  • Ensure the accuracy and integrity of environmental monitoring data and records.
  • Assist in monitoring the Environmental Management System (EMS).

Reporting, Tracking, and Trending of Adverse Events:

  • Report adverse events identified during review of environmental monitoring data to department leadership.
  • Assist in the tracking and trending of EM data to identify repeat adverse events and any potential trends within the data.
  • Complete initiation of investigations when adverse events are identified and assist in writing investigations as needed.

Issue Resolution:

  • Complete data evaluation to determine if objective evidence exists for an identified adverse event that can be used to remediate the event.
  • Work collaboratively as a team to improve existing environmental monitoring processes and / or assist in the creation of new environmental monitoring procedures and training course plans.
  • Provide support for investigations.

Support for Audits:

  • Support regulatory and customer audits by providing requested documentation and evidence of compliance.
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