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Facilities Compliance Assistant (Temporary) - United States  

Company managed [?] Still accepting applications

Posted on : 10 July 2017

Project Description

Description:
  • Our company  is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. 
  • We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. 
  • These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
  • Our company will continue to focus on advancing therapies that are the first or best of their kind. 
  • 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


Equal opportunity:           
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.