Details: Job: Supervisors Team Leaders & Coordinators JOB TITLE: Quality Management Associate SUPERVISOR: Manager, Quality ManagementGENERAL SUMMARY OF DUTIES- Assist with Information Technology (IT) audits. Plan, organize, and/or deliver system training and educational programs. Assist with all learning-related technologies.DUTIES INCLUDE BUT ARE NOT LIMITED TO:• Assist with IT orientation and training of new employees.• Attend training courses, conferences or association meetings to continue to gain knowledge and to share such information with other members of the group or company to increase their awareness.• Perform audits of internal and external technical and research operations to assess the level of compliance with company standards, policies, practices and procedures and current regulationsand guidelines.• Appropriately escalate any compliance issues.• Maintain a comprehensive knowledge and understanding of all applicable regulations, technical knowledge, and training.• Participate or lead the preparation and/or review of standards, policies, procedures and guidelines that are used to establish quality requirements, when needed.• Apply current knowledge of IT trends and systems processes to identify security and risk management issues and other opportunities for improvement.• Participate or lead the preparation of organizational metrics and trending of audit findings, when required.• Provide advice to research operations on the interpretation of corporate and regulatory requirements (standards/policies/procedures) related to quality management, when required.• Provide technical expertise in identifying, formulating, assembling and delivering quality andcompliance education to customers, as required.• Maintain good interpersonal and communication skills with auditees and business areas with particular emphasis on verbal and technical writing skills.• Be continually aware of current industry trends and regulatory agency interpretation of GxP requirements.• Mentor others in the implementation of requirements.• Representing QA dept. to Company and Sponsors.• Assist with IT and IT Clinical Applications SOP development and other areas as required.• Assess systems related procedures for data collection relative to study protocol.• Maintain knowledge of SDLC methodology and ability to audit systems against the methodology and applicable regulations.• Assist with Quality Management System administrator duties working closing with IT Clinical Applications department to ensure the full benefit of the system, as needed.• Perform audits of internal and external technical and research operations to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines.• Perform other duties as assigned by manager.• Practice and adhere to the 'Code of Conduct' philosophy and 'Mission and Value Statement'• During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
No comments:
Post a Comment