Provide daily operational support for all Quality functions including documentation control, issuance and tracking of OOS, Deviation, MRB, EMIs, etc., provide GMP and core competency training, review of quality data (validation, stability, batch analysis, environmental, etc.) and disposition of raw materials, intermediates and final product. Assures that the Equipment Calibration Program and validation complies with the GMPs requirements. Coordinates interdepartmental activities.
The QA Manager, Compliance and Documentation is responsible for providing cGMP compliance and documentation support to the site operations in Lexington, MA. The compliance and documentation team manages and supports to create, review and approve documentation, including standard operating procedures, protocols and reports. This role drives manufacturing compliance to meet various regulatory requirements and quality systems in a GMP environment. The compliance and documentation team will manage deviations, CAPAs and change controls with the support of appropriate personnel. This role also responsible for continual monitoring of quality indicators; trending, tracking and metrics reporting, and escalation, as appropriate.