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Facilities Compliance Assistant
Manufacturing / Production / Operations
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