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 co...