Quality Specialist

Act as a liaison for Director of Quality Assurance as applicable

  •       Coordinate and perform audits, quality initiatives and quality assurance communications as delegated by the department Director·        Perform Quality reviews for required documents·        Perform external audits to ensure quality control is conducted according to SOP·        Coordinate the reporting, investigation and resolution for the Error Management process·        Assess new guidance’s documents, standards or regulations for external agencies or contract facilities and assists in the development of action plans for implementation.·        Participates in the monitoring of the quality control (QC) process·        Prepare and present reports on quality indicator tracking and trending during Quality Committee meetings and as requested·        Participate or lead facilitation of improvement which lead to improved processes and/or reduced costs through quality improvement methodology 
  • ·        Review and edit as appropriate Standard Operating Procedures and associated forms
  • ·        Submit correspondence including: licensure, deviation reporting, CBER Annual Report and other major changes to external agencies and contract facilities
  • ·        Facilitates external inspection visits
  • ·        Assist in the preparation and coordination of external inspections
  • ·        Assess the effectiveness of corrective actions taken by operations in response to audits, reportable events, etc. to monitor quality improvement
  • ·        Perform or coordinate monitoring of Supplier Qualification program (critical supply issues, manufacturer notifications, etc.)
  • ·        Work process implementations to ensure new technology or process implementation occurs within the expectations of validation or implementation plans

PLEASE APPLY & UPLOAD RESUME USING THIS LINK: https://loxo.co/job/218497

Experience :
3-5 years
Wage :
Job Location :
Creation date :