System One Services Quality Engineer QA Support in Devens, Massachusetts

Quality Engineer QA SupportDevens, Massachusetts




Category:Scientific & Clinical

Job ID:118373

Date Posted:06/14/2017

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.