IT Quality Specialist

We are seeking an IT Quality Specialist to lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. The individual will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.

Requirements

• Review validation/qualification packages of computerized systems for completeness and accuracy
• Serve as Owner or QA Contact for Minor and Major Deviations
• Participate and support regulatory inspections
• Drive Change Request (CR) and Change Control processes
• Review and approve all validation documentation
• Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices
• Review and approve System Life Cycle Documents prior to their use in production
• Data Integrity Assessments: Review and approve data to ensure data is accurate and complies with regulatory standards
• Periodic Review/Audit Trail: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance
• Supplier Evaluations: Provide support for supplier evaluations as needed
• Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required

Benefits

• Competitive benefits
• Comprehensive Total Rewards Plans
• Collaborative culture
• Professional and personal growth and well-being support