Stephanie M. B. Email & Phone Number

Waltham, Massachusetts, Us

Provide technical and consultative support to Laboratory Staff and Quality Assurance Departments.Develop the Quality Management Systems strategy and the management arrangements for key milestones, demonstrating solid progress against plans and objectives.Manage all external registration requirements to ensure they are met. Liaise withexternal bodies on all matters relating to registration. Maintain and improve, in line with business needs.Implement all relevant procedures described in the Quality Management System (QMS).Ensure that all in-house systems and procedures are updated and revised to meet the needs of external certification bodies whilst ensuring simplicity and understanding for their use.Revise quality documentation and communicate to carry forward lessons learned from quality concerns.Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits.Introduce new systems and procedures where appropriate.Train others in all aspects of the quality system and application of procedures.Undertake regular internal/external process audits of the QMS.Ensure corrective actions are undertaken to address non-conformities found. Verify and ensure timely closure of non-conformities.Provide detailed analysis of the QMS KPIs to senior management.Ensure ongoing compliance with the QMS.Lead Naveris Quality Committee meetings ensuring all aspects of the QMS are discussed and any actions are driven to satisfactory completion.Ensure KPIs are met by working to the overall plan, including management of, and reporting.Ensure that the function operates in accordance with any health, safety and environmental policies and procedures to ensure the safety and wellbeing of staff and visitors.Identify and ensure suitable risk management processes are in place.

Secaucus, Nj, Us

Implementation of quality management system for R&D project at siteEnsures that the quality management system demonstrates regulatory compliance per FDA CFR Part 820 (QSR), ISO 13485 (Quality Systems), ISO 14791 (Risk Management), IVDR 2017/746 (In-Vitro Diagnostics Medical Device Regulations) and other applicable Federal, State and local regulationsTrain internal/external staff on quality management system requirementsPrepare management representative meeting data/presentation as representative for site for Quality Metrics. Trend Quality data. Monitor trends and create reports for management reviewWork closely with other department staff members to assist with CAPA assignments and ensure compliance of FDA, ISO and various regulatory requirementsSit on R&D project team meetings as the quality representative and assist/train R&D team in Design control documentation including risk management activities per ISO 14791Coordinate, manage and follow-up on quality projectsConduct/participate in quality audits (internal and external) and regulatory authority inspections (BSI) to ensure risk to company is minimizedEnsure appropriate design control documentation is developed and design history file is maintainedReview and approve change control documentsEvaluate the development and deployment of testing assays for the appropriate laboratory disciplineUpload / Review / approval of standard operating testing procedures prior to issuance for implementation to help ensure accuracy of testingQuality review and approval of batch recordsApprove release of materials based on product specificationsInvestigate quality issues identified within Quest Diagnostics laboratories and facilitate problem resolutionCollaborate with other Quest Diagnostics sites/departments to meet desired outcomesSupport implementation for assays across Quest Diagnostics facilitiesMediate discussions between subject matter experts regarding testing and test systems

Secaucus, Nj, Us

Direct, advocate for and enable visibility of quality processes. Ensure accountability within all areas of the business unit (pre-analytical, analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality. Direct internal inspection process of the business unit, associated laboratories and specimen collection sites to ensure compliance with applicable federal, state, and local regulations, NYS Department of Health Wadsworth Center, College of American Pathologists (CAP) / Clinical Laboratory Improvement Amendments (CLIA) accreditation requirements and Quest Diagnostics standards. Review event log and ensure that corrective action is implemented when non-conformances are found.Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards to ensure laboratory compliance.Ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations. Collaborate with business unit management even if primary responsibility has not been assigned to QA.Identify all tests performed and ensure enrollment and participation in external proficiency testing.Conduct monthly QA meetings with required participation by all areas having an impact on pre-analytical, analytical and post-analytical phases of testing. Develop, monitor and improve Quality Assurance specific quality indicators, including but not limited to: Reportable Quality Issues, PT outcomes, Revised Reports tracking, and performance on inspections. Implementation of weekly walk through of the laboratory areas to ensure inspection readiness.Prepare, revise and distribute a QA Manual that includes local QA policies. Ensure all applicable employees are trained and compliant with policies.Ensure a process is in place to resolve customer complaints regarding pre-analytical, analytical, and post- analytical issues.

Worcester, Massachusetts, Us

Act as primary point of support for the end-user to assist with and correct issues related to supported applications. Identify, analyze, solve, and/or escalate EMR issues with end users.Manage Electronic Medical Records (EMR) system and train hospital personnel in all aspects of system used to ensure meeting Meaningful Use (MU) goals, including troubleshooting system problems.Maintain system administration tasks for enterprise systems as required.Work closely with IT Director and management to prioritize requests for support and application enhancement.Support IT change control policies and procedures to ensure compliance.Complete special projects as requested (Project Manager for outsourced pharmacy prescription interface project in April 2017).Provide IT support for seven locations within Massachusetts and Rhode Island.Troubleshoot Networking and Software applications.Aid in developing/training of system processes, procedures and policies for hospital staff.Practice Continuous Improvement for the IT department.

Illinois, Us

Maintain Compliance Audit Quality Systems in accordance with applicable regulatory requirements.Manage the tracking, reporting, dispositioning, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions for all audits performed.Prepare for Internal/ Supplier audits/assessments by researching background information, including previous audit results. Perform the audit/assessment by collecting and analyzing objective evidence regarding issues and risks. Report findings to management team. Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Communicate issues to management team. Manage the assessment file through the process to closure utilizing Trackwise 7. Perform follow-up audits to confirm corrective and preventive action is effective. Support and participate with management during external inspections as needed. Participate in continuous improvement initiatives such as QLP, Lean and 6-Sigma. Support plant-wide strategic plan programs and activities.

Worcester, Ma, Us

Worked directly with Laboratory management to implement and manage the Performance Improvement Plan for the Hospital Laboratories. Ensured laboratory preparedness for CLIA, CAP, DPH and Joint Commission inspections by conducting mock inspections and self-audits as directed.Ensured SOPs existed for all procedures performed in the hospital laboratories.Developed, reviewed and documented training and educational programs for personnel including new employee orientation, as well as safety, SOP, and technical training.Participated in administration of principles of Error Management Program; reviewed quality procedures to ensure all complaints properly investigated; and ensured procedures were in place for thorough investigation and complete documentation.

Worcester, Ma, Us

Assisted in the implementation, installation and testing of laboratory information systems and related interfaces for the Hospital Laboratories, ensuring accurate and useful applications.Consulted with Hospital Laboratories staff, physicians, IS, and other users as well as Hospital Laboratories, Outreach clients and other team members to facilitate smooth operation of computerized system. Developed procedures to assure smooth and auditable transition of new interfaces from test mode to operational status.Lead analyst for Cellavision interface (hematology analyzer) for implementation, installation and testing.Participated in quality assessment and improvement activities and TQM programs to ensure compliance.

Hopkinton, Massachusetts, Us

Provided Psyche Lab Information Systems technical support via phone and email.On-site training at customer sites for Blood Bank module. Interacted with software programmers to repair errors/bugs reported by customers. Tested and performed quality assurance of enhancements and modifications to software.Designed training materials, and reference guides for customer learning and retention. Evaluated and revised support procedures.Account manager responsibilities which included annual review of contract details.

Worcester, Ma, Us

Per diem positionFollowed established Blood Bank protocols to perform tests including the most complex for an assigned area and prepare component blood product for transfusion.Maintained accurate records of tests performed using MEDITECH computer system.

Rockville, Md, Us

Formerly Q-OneQuality review of Good Laboratory Practices (GLP) reports and supporting documentation (assay data, study protocols, testing support documentation.Completed review of facility documentation for compliance to internal procedures, GMP, GLP and FDA guidelines.Reviewed and approved deviations, amendments and investigations.Performed step audits at pre-determined critical points of study protocols, validations and assay technology transfers.Conducted internal audits for adherence to internal procedures and quality systems with initiation of corrective and preventative actions when needed.Quality review of equipment protocols and reports (PM, Calibration, IQ/OQ and user SOPs).Assisted in deviation issuance, tracking and trending. This includes includes CAPA, investigation of root cause and corrective action.

M.S., Business Administration And Management, General

Bachelor Of Science (Bs), Medical Technology, Zoology

Education record