Remote: Sr. External Quality Specialists (232186) Client is in the gene therapy space and is looking for a contract resource to step in and help them in the External Quality and Compliance space. There is only 1 other person in this group at the time and manager needs to bring in another experienced resource who can help manage the workload. Extensive volume of change controls, batch record review, deviation work coming from their CMO’s. Work is pertaining to management and oversight of the CMO’s and making sure they are running their systems within compliance. In the end this is the client’s product so need to make sure the resource has an eye for Quality and is able to oversee CMO activities as they relate to Quality Documentation; Batch Disposition Documentation, Change Control Documentation, Deviation Reports, etc. It would be great if candidates were out there who started in QC/Analytical and then moved into the QA Space. It would be even better if they had some Gene Therapy mfg experience. If they don’t have C&G Therapy, but have some QC Analytical that is the trade-off. Client is looking for a hard worker who has good work ethic and able to juggle multiple tasks at once. Not looking for managerial/Director level experience or process improvements. Need’s a good contractor to do the work.