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SummaryLaboratory Manager/Team Leader with regulatory compliant clinical operational experience. Project management skills with supportive team building/mentoring initiatives. Effective audits of processes, training/technical report reviews to support standardized corporate initiatives.Capabilities: Project Management  Training  Time Management Constraints  Create/Review SOPs/WI/Change Control  Oversight/Input to Investigations/Deviations/CAPAs  Regulatory Compliance/Inspection Readiness (lab maintenance)/Building Support Services  Quality Control/Assurance  Documentation/Authorization  Vendor Management/POs  Continuous Improvement  TMF support  Inventory Control  FDA/GMP complianceProfessional ExperienceClinical Programs and Compliance Specialist, Fujirebio Diagnostics, Inc. April 2022-CurrentVendor and risk management, contract negotiation, clinical supplier control, regulatory compliance, departmental training and standardization of SOPs, responsible for communication and template report documentation, continuous performance improvement, monitor key performance indicators. QA audits, Oversight/Input to Investigations/CAPAs, Quality Systems/Processes, GLP training.Independent Biomedical Research Consultant, (Wuxi Aptech, Johnson and Johnson & Hassman Research Institute) Sept,2020-Mar 2022Project Management/timeline tracking, supply chain initiatives, budgetary metrics, report documentation, inquiry resolution, management oversight/collaboration with cross-functional teams/contract negotiation, supply training, regulatory documentation compliance, effective and efficient communication, develop and review standardized SOPs, risk management and mitigation.Quest Diagnostics, Horsham, PA: Patient Service Center Supervisor Nov,2019- Aug,2020Responsible for management of employees in multiple departments and multiple locations (PSCs) in a satellite operation. Responsible for the quality of services and technical procedures and overall patient experience and patient safety initiatives. Ensure compliance with applicable testing requirements, regulations, and departmental budgets. Supply training, mentoring and coaching. Monitor key performance indicators, supply chain responsibility, supply reports of activities.1.Formulate operational aims, goals, and strategies for assigned facilities. Oversee patient safety initiatives. Supply effective and efficient oral and written communication.2.Investigate effective methods to increase fiscal responsibility and efficient services including researching and implementing innovative technologies and ways to capture proper data.3.Ensures adherence to compliance guidelines and monitoring of budgets and profitability of PSCs, and sites, including procuring supplies and services through effective contract negotiation and implementation.PRA Health Sciences, Marlton, NJ: Project Manager of Laboratory Operations Dec 2015-April 2018Laboratory Team Lead support and input to the study specific execution of contracted Pharmaceutical Clinical Trial Protocols in conjunction with a collaborative interdisciplinary Research Team. Selected Accomplishments include:a.Evaluation/acquisition/implementation of system to streamline subject flow through clinical areas to reduce turnaround time through investigation and contract negotiation.b.Utilized study specific checklists to effectively execute/delegate all laboratory tasks of multiple clinical trials simultaneously to reduce numbers of queries and audit findings.c.Decreased routine supply shipping expenses through implementation of a replenishment system to alert vendors when inventory was diminishing and needed replacement.d.Improved regulatory compliance through acquisition and installation of a temperature monitoring system and a maintenance system for equipment calibration.Jennersville Community Hospital, Jennersville, PA, Laboratory Manager May,2014-Nov 2015Piloted leader supported hospital management initiatives, revitalized staff and department and advocated laboratory data and information to unit clerks, floor nurses and physician offices. Accomplishments include:Achieved efficient and effective oversight to all aspects of Clinical Laboratory ServicesInspired departmental performance improvement through team building processes.Monitored budgetary benchmarks to decrease OT and check key performance indicators.Attended hospital management team meetings with input from the laboratory department.Negotiated with vendors to secure modernized equipment and systems.Conducted Performance Evaluations for staff in conjunction with HR guidelines.Education:Doctor of Healthcare Administration (DHA), University of Lynchburg (VUL). Lynchburg, VAMaster of Health Administration (MBA), Eastern University, St. Davids, PABachelor of Organizational Management, (BA), Immaculata University, Immaculata, PAAssociate of Laboratory Science (AS), Harcum College, Bryn Mawr, PACertificate of Higher Education Teaching, Harvard University, Derek Bok Center for Teaching and Learning