Quality Control Associate Scientist - (Brockton, MA)

The Quality Control Scientist will lead the execution of technical transfer and co-validation activities for the QC network; and support QC operations with equipment/ method troubleshooting. Responsibilities Write, Review and Approve technical protocols and reports. Recognize and recommend solutions for instrumentation and method issues. Operate independently on testing and methods including data review and demonstrated ability to recognize anomalous trends or results. Peer review/ approval of lab data generated as a part of method transfer/ validation activities. Support implementation of analytical method change control as needed throughout the BMS network, 3rd party manufacturing and outside testing labs. Skilled at authoring validation protocols and final reports; Works according to cGMP requirements and HA expectations. Responsible to lead complex major/critical QEs, drive effective root cause and CAPA, provide rationale and justification for changes to requirements for ongoing investigations.