Senior Quality Systems Specialist

Job description

The Specialist will be a primary partner on: · Developing and supporting the INCOG approach to investigation processes. · Developing and supporting the INCOG approach to deviation trending and tracking. · Developing and supporting Change Control and CAPA review and evaluation board(s). · Generating Quality Management System metrics, dashboards, and reporting. Working closely with the Quality Systems Team and cross-functional departments, the Specialist will be instrumental in engaging the site in performing Deviation Triage, change plan development, change actions and CAPA creation. The Specialist will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments. The Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Specialist will have strong familiarity with industry standard Deviation/investigation, root cause assessment, risk assessment, change management, and CAPA processes. The Specialist will have...