Direct cross - functional quality improvement teams demonstrating significant improvement in key quality metrics. Implement process control plans for the value stream focusing on critical to quality criteria and reaction plans.
Lead internal audits, coordinate third-party audits, resolve customer complaints, lead continuous improvement projects, manage the calibration system, help establish product specs and support Production through SPC and advanced statistical analysis.
The QCM will stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control Analytical & Microbiology Laboratories and the Incoming Inspection departments are complaint in the areas of applications, release specifications, and documentation practices.
Develop and continually update the production schedule on a weekly, monthly and quarterly basis and ensure alignment/adjustment of manufacturing schedule to meet development program milestones and corporate goals, as appropriate.