Beth Boyce Email & Phone Number

North Chicago, Il

North Chicago

North Chicago

Maryland Heights, Mo

Provides overall quality support to the cold products manufacturing focus factory by giving quality insight to the aseptic filling production process and packaging inspection.Performs thorough exception, OOS, and customer complaint investigations to determine product impact, root causes, and identify corrective actions Performs root cause analysis for investigations and CAPAsProvides training for new quality engineer on exceptions, change controls, CAPAs, and customer complaints Qualified internal auditor – performs audits against 21CFR parts 210 and 211 as well as site SOPsPerforms new hire contamination control and aseptic technique trainingParticipates on site charter to improve reduce the number of overall exceptions for the site

Maryland Heights, Mo

-Perform investigations to determine root causes and corrective actions for out of specification sampling results of viable and non-viable sample test results-Perform and write thorough investigations to determine root causes and corrective actions for the Environmental Monitoring department when deviations occur.-Evaluate, revise, and create departmental procedures-Develop and respond corrective and preventative actions and internal audit findings.-System Administrator for the Microbiology Information Management System (MIMS)-Maintain, update, and ensure MIMS remained current with all procedures and cGMP guidelines-Documentation review of Environmental Monitoring test reports-Revised and compile Environmental Monitoring Trend Reports, utilized for tracking and trending all environmental monitoring data collected throughout the Maryland Heights Facility-Developed performance qualification protocols pertaining to environmental monitoring performance qualification of new QC testing area and existing controlled environment area-Developed contamination control meetings to provide up to date trending to all APA departments while aiding in the reduction of bioburden throughout the facility-Maintained gowning certification program and performed aseptic gowning certification training to all newly and currently trained personnel-Performed area walk-throughs and observes APA filling activities to determine root causes and corrective actions for environmental excursions-Performed product release by ensuring all acceptance criteria are met for environmental monitoring performed-Assisted the microbiology department with executing media fill qualifications and reviewing of environmental monitoring test results

Maryland Heights, Mo

Performed environmental monitoring in accordance to Standard Operating Procedures (SOPs) and regulations and guidelines set forth by the Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), and Occupational Safety and Health Administration (OSHA). Trained to perform routine monitoring in Class 100 (Grade A), 10,000 (Grade B) and 100,000 (Grade C) aseptic processing areas/controlled environment areas under both static and dynamic conditions.Working knowledge of cGMPs in relation to a pharmaceutical aseptic processing atmosphere.Microbiology Information Management System operation (trending, data entry, review).Proficient in aseptic techniques and their application in the manufacture of parenteral drug products.Aseptic gown certified to perform routine tasks in Class 100 (Grade A) sterile environment.Qualified to work in isolators and RABS (Rigid Access Barrier Systems).Supervisor nominated trainer for both demonstration and qualification of departmental tasks/responsibilities.Proficient in viable air (active and passive methodologies), viable surface (swab and RODAC methodologies), and non-viable air sampling conceptsProficient in the use of SAS, SMA and Met-One particle counters.Performed WFI sampling and total microbial count testing on water for injection via membrane filtration.Trained in writing and revision of exception reports to justify deviations from procedures and identify corrective and preventative actions (CAPAs).

Master Of Business Administration (Mba)

Bachelor Of Science (Bs), Biology, General