Stability Coordinator

The Stability Coordinator is responsible for the smooth tracking and operation of all stability studies on site. This job requires the ability to demonstrate a high commitment to interpersonal relations. The Stability Coordinator works closely with Chemistry, Microbiology, and Client Services Department Management. This position presents the employee with an opportunity to play a key role in stability studies which includes Study Management, sample pulls, sample/study initiation, Regulatory Compliance, and Data Management while simultaneously learning the technical skills required to advance in the field of stability studies.Performs a variety of activities to help administer the stability program at SGS Life Science ServicesResponds to customer requests for information concerning stability studiesAssists in the preparation of stability protocols and final reportsPerforms any needed stability trending as outlined in the stability protocolStability Protocol and Report writingAbility to write deviations, OOS and CAPAPrepares samples for inclusion in stability studies, including labeling and distribution to the appropriate stability chamberRemoves samples from stability chambers according to protocol pull schedules and submits them to the appropriate testing group or outside customerMaintains stability chamber inventory and monitors chamber performanceUtilizes LabVantage LIMS to manage and track studies to completionPerform a quarterly inventory of stability samples, with special attention to control samplesMaintain thorough knowledge and understanding of all Standard Operating procedures (SOPs) pertaining to testing, review, and equipment calibration and maintenanceMaintain thorough knowledge and understanding of general SOPs, GMP/GLP, and ISO regulations as it pertains to work performed in the laboratoryMaintain knowledge of current compendia and testing methods as they apply to stability studies and knowledge of FDA guidelines regarding stability requirementsAble to work with minimal guidance to take a project from start to finishAdherence to relevant SOPs governing documentationParticipation in general staff meetings and training sessions as scheduled by Client Services Management