Instrument Qualification Specialist

Responsible for the qualification of laboratory instruments with robust experience on CSV and System Development Life Cycle (SDLC), URS, VP, DQ, FRS, SDS, IOPQ, TM, etc. It is required a lot of remote communication between the working group; bi:weekly one on one meetings with the client and weekly team meetings to review progress. TASKS: Participate as part of a cross functional global project to qualify QC instruments and associated software. Support the implementations of a new standardized global qualification for QC instrumentation and associated software. Implement validation strategies for QC instrumentation and associated software, across QC Laboratories. Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as: Network QC Instrumentation Standardization and Windows 10 upgrades. Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments. Author qualification related deviations, identifying root causes and robust CAPAs. Author qualification related change controls and validation plans. Update procedures and documents to implement data integrity controls arising from instrument qualification programs. Serve as liaison with lab:IT teams to harmonize QC instrument's software configurations where applicable. Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation. Provide updates on qualification status, project timelines, and escalate challenges as required. Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team. Requirements EDUCATION / EXPERIENCE - Bachelor of Science