analytical laboratory manager

I have a hands-on experience interacting with suppliers, internal customers, and subject matter experts to ensure thorough evaluation and accuracy of discrepancies and investigations, identifying root cause, coordinating corrective and preventive action plans, writing summaries, and reviewing reference documents. I am experienced in change control process for externally initiated material changes in accordance with cGMP, US, and EU regulations. I’ve successfully directed supplier process and operational reviews of manufacturing and testing processes, and kept senior management informed of observed quality discrepancies and provided timely impact assessments of potentially affected products, materials, or processes. I had reviewed and updated Quality Agreements at different development stages. I have knowledge of chemical manufacturing processes, laboratory tests including compendia methodology, analytical and process validation programs, and use statistics for results evaluation. My work required to make sound decisions about scheduling, coordinating, and managing priorities, strong interpersonal skills, and project management experience and influence others.

Agricultural Technician

San Mateo, CA