Quality Systems Coordinator

Quality Systems CoordinatorThe Quality Systems Coordinator supports the maintenance and execution of the Quality Management System (QMS) to ensure compliance with cGMP and regulatory requirements within a cell and gene therapy environment. This role is responsible for coordinating quality system processes, maintaining documentation, supporting investigations, and facilitating continuous improvement activities.Duties And ResponsibilitiesThe following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned.Maintain controlled documents and training records within eQMSCoordinate and maintain Quality Systems including deviations, CAPA, change control, and document controlEnsure accurate and timely documentation in alignment with cGMP requirementsTrack and report quality system metrics and KPIsSupport investigations and root cause analysis activitiesAssist with CAPA tracking and effectiveness checksSupport internal and external audits and regulatory inspectionsCoordinate cross-functional communication related to quality systemsIdentify opportunities for continuous improvement and support implementationEnsure compliance with internal procedures and regulatory requirementsQualificationsBachelor's degree in Life Sciences, Engineering, or related field (or equivalent experience)2–5 years of experience in Quality, preferably in pharmaceutical, biotech, or cell & gene therapy industryFamiliarity with Quality Systems (CAPA, deviations, change control)Knowledge of cGMP and regulatory expectationsExperience with electronic Quality Management Systems (eQMS) preferredStrong organizational and documentation skillsPhysical DemandsFrequently required to standFrequently required to walkFrequently required to sitFrequently required to talk or hearOccasionally required to lift light weights (less than 25 pounds)Specific vision abilities required include close vision, color vision and ability to adjust focusWork EnvironmentThe noise level in the work environment usually is quiet.Work may be performed in office, laboratory, or GMP manufacturing environments.Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.