6437 - Senior Quality Engineer / Senior Quality GxP Auditor

Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Senior Quality Engineer Responsibilities: Quality Oversight & GMP Operations Provide Quality Assurance oversight for GMP manufacturing operations supporting both clinical and commercial Cell & Gene Therapy products. Partner with Manufacturing, Validation, Engineering, Facilities, Laboratory Operations, Materials Management, and Capital Project teams to ensure GMP compliance throughout the product lifecycle. Represent Quality on cross-functional project teams while serving as the primary QA resource for assigned initiatives. Identify compliance risks and proactively communicate quality gaps, recommending practical, risk-based solutions. Validation & Engineering Support Provide QA review and approval of: Validation protocols and reports Equipment, utility, facility, and computer system qualification documentation Risk assessments Engineering change documentation Support commissioning, qualification, and validation activities associated with manufacturing equipment, facilities, utilities, and capital projects. Review qualification activities for laboratory instruments and manufacturing systems. Quality Systems & Compliance Provide Quality support for: Change Controls Deviations and GMP Investigations Root Cause Analysis Corrective and Preventive Actions (CAPA) Ensure investigations are scientifically sound, timely, and compliant with regulatory expectations. Evaluate quality issues using a risk-based decision-making approach. Facilities & Utility Oversight Provide Quality oversight for: Preventive Maintenance (PM) Calibration programs Electronic Change Requests (eCRs) Work Orders Review and approve equipment, utility, and facility trending programs. Support Environmental Monitoring (EM), routine facility monitoring, and utility control programs. Provide oversight of facility monitoring systems including Building ...