System One Services Quality Engineer QA Support in Devens, Massachusetts
Quality Engineer QA SupportDevens, Massachusetts
Category:Scientific & Clinical
Quality Assurance Engineers needed for global pharma company!
Must haveminimum of six years of experience in biopharmaceutical quality
Experience in review and approval of qualification/validation protocols and reports required.
Experience in review and approval change controls
Extensive knowledge of US and EU cGMP regulations and guidance
Knowledge of biotech drug substance manufacturing and analytical testing
Knowledge of manufacturing executions systems such as Syncade, SmartLab; and distributive control systems such as DeltaV is highly desirable
Knowledge of applicable business systems including: SAP, LIMS, Maximo and Trackwise.
Experience in technical transfers and working in facilities with extensive use of automation is highly desirable
Will be asked to perform QA review and approval to support existing drug substance manufacturing and/or future drug substance manufacturing of equipment qualification, process & automation validation and critical utility/facility protocols.