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Quality Systems Specialist

SUMMARY

The Quality Systems Specialist position reports to the Quality Systems Manager.  The Quality Systems Specialist will assist with the administration, configuration, and management of all Quality Related Systems which includes but not limited to the following: Document Management Systems, Training System, Laboratory Information Management System (LIMS), Laboratory Systems etc.

 

RESPONSIBILITIES

  • Responsible for ensuring Regulatory and Clinical documents are configured, migrated, and stored in MasterControl.  The Clinical and Regulatory documents includes but not limited to the following: clinical protocols, investigator’s brochures, informed consent forms, annual reports, investigational new drug applications, new drug applications, regulatory correspondence, and clinical summary reports
  • Participate in regulatory inspections, internal or external audits and assist in the preparation of information requested by regulatory agencies or internal/external auditors.
  • Provide assistance to the clinical and regulatory teams to ensure and maintain technical and regulatory documents and files within MasterControl
  • Responsible for training employees on the use of Mastercontrol for documents, training, incident reports, deviations and CAPA.
  • Assist Manager in providing support on the use, administration, and configuration of the Electronic Document Management System and Learning Management System (MasterControl)
  • Support training for Environmental Health and Safety department to meet OSHA Regulations
  • Build, develop and maintain data models, reporting systems, data automation systems, dashboards and performance metrics support that support key business decisions
  • Assist the Document Control and Training team in troubleshooting document related issues and/or assist the document control team in reviewing documents, approving Document Change Requests, and generating controlled copies, when needed
  • Assist Manager in providing training, technical support, and maintenance services on the following Quality Management Systems:  Mastercontrol QMS, LIMS, MODA, etc.

 

REQUIREMENTS

  • Must have a Bachelor’s degree with 3 years experience in the FDA regulated environment or a Master’s degree with 0 years experience
  • Must have knowledge in clinical and regulatory affairs document process
  • Must have technical knowledge on the use of the MasterControl Quality Systems Modules (Documents, Training, Incident, Deviation, Change Control, CAPA)
  • Must have proficient knowledge of computer applications in the Microsoft Office Suite; including scanning of documentation.
  • Must have excellent written and verbal communication and interpersonal skills
  • Must be proficient in the use of computers including a wide variety of word processing and spreadsheet software packages

 

 

               

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