Participate as part of a cross functional global project to qualify QC instruments and associated software
Create, execute, and review network-led QC instrument/software qualification documents in support of global QC projects
Support the implementation of a standardized global qualification for QC instrumentation and associated software across multiple QC sites
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
Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team.
Support general QC asset management
Coordinate/interface with vendors for servicing/maintenance/upgrades
Execute periodic assessments/decommissioning
Bachelor’s degree in relevant scientific or computer area with 7 – 10 years’ experience in the biopharmaceutical industry; OR
MS degree with 6+ years’ experience or equivalent combination of education and experience.
Minimum 6 years’ experience in a role either (a) QC instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
Demonstrated expertise in large projects, prioritizing workload with minimal supervision
Demonstrated ability to work independently as well as contribute to a team based collaborative environment
Self-directed with a high degree of professional integrity, organization, and attention to detail.
Strong interpersonal, oral, and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.