Subject Matter Expert (SME) - Maintain instrument/software in a validated state at all times. Perform assessment, trouble-shooting, repair. Develop and implement CAPA to resolve issues as needed. Ensure completion of preventative maintenance and routine qualification testing. Install, configure software for electronic record compliance. Perform testing to identify gaps and develop remediation as required. Routinely analyze system logs/audit trails, perform software/firmware upgrades, update user account information, and complete periodic system compliance reviews.Validation Testing - Determine and/or assist with determining the approach to test and validate instrumentation. Provide technical and risk-based rationale to support approach. Coordinate installation and/or execute testing (as required).Review testing documentation generated by vendors and/or other team members. Compile and maintain documentation in an organized GXP compliant manner to demonstrate status.Applies GMP/GLP in all areas of responsibility, as appropriateCompliance - Ensure projects are completed in compliance with existing quality systems. Stay current with client, regulatory, validation, IT, and e-record regulations and requirements. Assist with implementing new internal practices and procedures.Research - Research and on-board new instrumentation; Assist with integration of instrumentation into existing data center environments and workflowsTechnical Writing - Provide technical input for validation deliverables, investigations, and develop/enhance procedures in accordance with established quality programsTraining - Provide training to system users and other admins; Assist with developing training program and proceduresConducts all activities in a safe and efficient mannerPerforms other duties as assigned
