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Facilities Compliance Assistant

  • Administration of the SAR (System Area Release) process
    • The SAR process is used to take GxP systems temporarily out of service and bring them back into use in a controlled manner. The Assistant’s SAR responsibilities include (but is not limited to):
      • Day-to-day management and tracking of SARs to completion
      • Daily email communication to a wide audience on SAR statuses
      • Working with Facilities planning and scheduling to ensure SARs are in place for routine maintenance and repair tasks
      • Training new supervisors and mechanics on the SAR process
  • GxP Pest Control: Responsible for managing contractor routine site visits, contractor training, and change requests/deviations/preventive maintenance related to the system. Also maintains paper records and metrics for audit purposes.
  • Monthly audits of GxP work orders for completion and adherence to general SOPs (Standard Operating Procedures)
  • Maintain personal training record with no assignments past due.
  • CMMS (Computer Maintenance and Management System): Ability to initiate work orders and notifications. Must develop advanced knowledge of the system, including report generation and ability to research equipment history.
  • Technical report writing
  • Other duties as requested by Facilities management
  • Strong computer literacy: highly fluid and proficient with Office software (Outlook, Word, Excel, PowerPoint at minimum), ability to perform data analysis and graphing in Excel.
  • Ability to quickly learn and master software used for management of Facilities Operations (e.g. CMMS, Pi Historian, SCADA) and Quality Systems (e.g. Trackwise)
  • BA/BS degree, preference in engineering, math, biological sciences, business or communications
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