Subject Matter Expert on qualifications related to Environmental Monitoring program and Contamination Control from the microbiological standpoint. Responsible for completion of room qualifications of controlled manufacturing areas. Responsible for completion of assessments to determine impact on the microbiological conditions related to manufacturing clean rooms. Author and complete Environmental Monitoring Performance Qualifications (EMPQ) related to the manufacturing clean/classified rooms in compliance with local and regulatory requirements. Coordinate sampling activities with EM sampling team and manufacturing department as applicable. Perform Failure Modes and Effects Analysis, as needed. Prepare and present to management the trend reports related to EMPQ and contamination control activities. SME of EMPQ and contamination control aspects providing leadership, technical and quality support to manufacturing and during regulatory inspections or site audits. Understands and assures conformance to regulations. Works with regulators during regulatory inspections. Interacts frequently with functional peer group and managers, as appropriate. Identifies and manages continuous improvement projects with the objective of achieving quality, reliability, and cost improvements. Sustain a clean and safe work area using 6S principles. Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). Author and revise Standard Operating Procedures as needed. Review and approve EMPQ and contamination control procedures, protocols, and reports. Perform Sterility Assurance Assessments as part of the Change Control Management process. Assist in establishing response plans to environmental out of limits. May be asked to lead classroom-based training for new employees and continuous education classes for established employees.

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