QC Document Specialist (GMP)

This is a hybrid, non-laboratory role supporting Quality and Analytical functions. The successful candidate will collaborate with internal teams and external partners to ensure data integrity, regulatory compliance, and timely execution of deliverables.Key ResponsibilitiesCollaborate with departmental colleagues to complete assignments under supervision.Review and interpret analytical data with client support; contribute to technical reports and regulatory documentation.Evaluate QC testing data for small molecule and/or biologics methods from external vendor laboratories.Enter GMP data into validated database systems accurately and efficiently.Verify data and trending tables for inclusion in regulatory submissions.Build and manage stability studies within validated systems, as applicable.Ensure GMP data aligns with current specifications; generate Certificates of Analysis (COAs) when required.Monitor and trend reference standards and analytical data.Identify and escalate routine technical issues or vendor-related concerns.Troubleshoot basic issues using available resources and guidance.Travel between Lexington and Cambridge client sites as needed.