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Click here or scroll down to respond to this candidateCandidate's Name
3 Chateaux Circle 3B, Scarsdale, N.Y. Street Address
(C) PHONE NUMBER AVAILABLEEMAIL AVAILABLEEDUCATIONFordham University, Bronx, N.Y.B.A. Natural Sciences 1990PROFESSIONAL EXPERIENCEBoehringer IngelheimSR Principal Specialist, QA January 2024 - presentManage deviations, Investigations and CAPA process, and change controls and determine potential impactLead working groups aiming at harmonizing and improving Quality System processes and/or serve as local Quality representative on Quality projectsLead in the organization, execution and follow up of GxP inspections and auditsPerform follow up of CAPA plansLead and conduct third party auditsLead and conduct in-process GCP/GLP audits and prepare reports within defined timelinesProvide Quality Assurance oversight for quality system documentsApprove, as QA, necessary procedures in place to cover GxP activitiesEnsure compliance of facilities and equipment by reviewing appropriate documentationConduct and provide training to Research and Development personnel to ensure knowledge of regulations, guidelines, and standards operating procedures (SOPs)Proactively identify additional training needs based on audit observationsIdentify opportunities for improvements and implement quality improvementsProvides timely and accurate reporting of appropriate measures of quality performance to Management (KPIs, QMRs)PDIInternal Auditor August 2023 December 2023Prepare and maintain the Internal Audit Schedule, including preparing the agenda with cross functional groups and Site Quality Assurance, conduct internal audits, prepare Internal Audit reports, follow up on CAPAs and close internal audits. Ensure internal audits are conducted per internal audit schedule and maintain internal audit files.Plans and perform QMS audits or departments and functional areas again drug, medical device, cosmetic, quality systems regulation and standards to achieve Site and Corporate compliance objectives.Make and present Quality Risk Management based decision. Determine when findings and audits are closed or require escalation. Participate and provide feedback into Management Reviews.Ensure CAPAs generated to address internal audit findings are audited for effectiveness. Monitor and report effectiveness of internal audits including CAPA plans, effectiveness checks and risk.Support the development and maintenance of qualification/certification program for Internal Auditors.Provide support in the development and monitoring of the effectiveness of the QMS throughout the organization including measurement, analysis and trending of policy and objectives implementation, identification of continuous improvement opportunities, training, and Management Review.Assist in Site Inspection and/or Audit Readiness activities and provide support during regulatory body inspections and customer audits.Collaborate with Subject Matter Experts to conduct external audits on suppliers, laboratories, and third-party manufacturers.Consistently demonstrate good judgement and critical thinking in the performance of Site Compliance activities. Support the Site Quality Assurance team as a valued partner, with a culture of safety, quality, delivery to patients, compliance and Data Integrity.Vertex PharmaceuticalsSr. Manager, GLP Quality Operations (Contract) May 2023 August 2023Ensures quality oversight activities maximize value, impact and deliverySupports scalable quality approaches and ensures consistency in execution of approaches across products and programsAssures compliance and excellence in quality and readinessParticipates in Regulatory Document Reviews, identifying any potential risks or gapsProvides input in development of audit scope/focus for vendor auditsContributes to pro-active inspection readiness activities, conducting quality assessments of GLP studies either on site or remotelyCollaborates with Preclinical stakeholders and quality partners to develop appropriate metrics related to GLP activitiesParticipates in creating/presenting content for annual GLP refresher trainingAlexion PharmaceuticalsAssociate Director, Research Quality Operations November 2021 May 2023Support the Research Quality Operations team to ensure quality and compliance for all laboratory related study activities from research through clinical development.Act as a customer facing strategic business partner for the Research organization by providing regulated (GLP/GCLP/CLIA) and non-regulated laboratory quality and compliance expertise and guidance.Support the evaluation, development, implementation, maintenance, and monitoring of fit-for-purpose quality systems and governance for the regulated and non-regulated areas within the research organization to ensure quality and compliance is built into the processes.Analyze issues and identify risks to provide the Research organization with advice and guidance through risk-managed solutions.Facilitate the assessment and investigation of quality issues. Provide expertise and recommendations. Ensure timely review and closure of quality issues through tracking and oversight.Support Research and CAPA identification and investigation, development, and implementation. Ensure timely completion and closure of CAPAs through tracking and oversight.Provide quality input to core Research documents and SOPs. Review Research SOPs to assure compliance with the regulations, internal policies and standards, and procedures.Ensure the regulated areas of Research are in a constant state of inspection readiness through robust process development and continuous improvement initiatives. Support inspection readiness activities as well as support any ongoing health authority inspections.Act as the GLP Archivist and primary person responsible for the oversight and management of the Alexion GLP Archives including the Research Study RepositoryReview and Approve Research Technical ReportsParticipate in audits as an SME, as neededReview audit reports of GxP Research vendors to detect trends of noncompliance issues both internally and externallyParticipate on computer system validation teams as regulatory compliance leadDevelop Quality Agreements for critical GxP Research vendors and oversee the implementation and governance of the agreementsMedidataSenior Specialist, Quality and Customer Management July 2021 November 2021Promote and adaptation of Medidatas Third Party Assurance and working cross-functionally to ensure control objectives are appropriately designed and operating effectively.Provide support for client audits, including:Scheduling, preparing for, hosting, and following-up on client audits of MedidataCoordinate audit responses and the preparation and delivery of Medidatas audit response to external auditorsProvide operational support to GCS-managed programs, including:Quality Incident (QI) managementException/Pilot programSupplier evaluation/auditQuality System Document managementInternal Quality System audit (in coordination with department-led operational self-assessments)Assist GCS management with activities related to client regulatory inspections and internal audits; and regulatory inspections of Medidata itselfRespond to requests from other departments within Medidata related to quality and regulatory information and documentation for clientsFulfill requests from GCS management related to the departments business operations (e.g., metrics, status updates)SanofiDocumentation Systems Management February 2020 May 2021Contribute to the definition and continuous improvement of the GMP documentation system (SOPs, Master Batch Records, Protocols, Reports, Site Master File, Quality Manual).Ensure the issuance / update of quality manual site master file and other site registration documentation that may be requested in the frame of the registration of the site.Responsible for managing quality documentation archiving, back-up, and retrieval.Contribute to the organization and provide support during regulatory inspections or audits.Contribute to the definition and continuous improvement of the training system (annual program, periodic refresh) and implementation of efficient tools to track the training status/progress of site personnel AND contribute to define and develop training programsResponsible for tracking and maintaining training system including database, training documentation, trends and metrics across the organization.Responsible for oversight of quality systems in GMP documentation.Design and Implement a system performance assessment and changes to improve as needed.Manage the of preparation, tracking, and implementation of more than 200 SOPs, protocols, and reports each year in a GMP environment.Responsible for the control of 10-20 Master Manufacturing Instructions per year the management of logbook and ancillary GMP documentation covering 300+ documents (logbooks, forms, contractor records etc.).Responsible for archiving system and primary liaison with SBS (75-100 executed batch records per year, executed protocols, maintenance and engineering records).Responsible for maintaining training system including records for 150 individuals per year and other training materials as applicable.Ensuring changes controls are adequately closed.Responsible for providing quality GMP training.Pentax MedicalComplaints Specialist (Contract) July 2019 January 2020Evaluate new complaints to decide if the information meets the definition of a complaint, assess risk level, and identify need for investigationAssess complaints/service calls to determine need for a Medical Device Report (MDR) and, if applicable, file reports within required timelinesInteract with appropriate stakeholders including but not limited to customers, medical professionals, field staff, and affiliates to obtain information pertinent to the complaintInvestigate complaints to determine root cause, identify resolution, confirm correction, and respond to complainantsMaintain oversight of assigned complaints to ensure timely processing while conforming to established procedures/processes, good documentation practices, and a high level of detail/accuracyReview and update complaint related procedures and work instructions as neededParticipate in assigned continuous improvement activities and participate in internal/external audit activitiesStrykerQuality Engineer (Contract) January 2019 July 2019Provide quality engineering support in quality assurance, advocate and lead the execution of initiatives & EUMDR project.Ensure compliance to regulation and standards.Work within the quality operations team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following: Work closely with operations and the business functions to ensure quality performance of product and processes. Participate in the development and improvement of the manufacturing processes for existing and new products. Review of change management activities. Develop understanding of risk management practices and concepts, ability to become proficiency in process risk. Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processesAnalyze, administer and implement programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement.Administer and maintain policies, procedures and methods to check product, material, components and/or operational quality and improve same.Ensure training via Compliance Wire.Administer and maintain policies, procedures and methods to evaluate and improve the quality of products, materials, components and/or operations.Assure and maintains the quality of products and processes, including standard procedures (e.g., ISO 9001:2000, ISO 14000 family of standards), quality audits/review, process reengineering.Siemens Healthineers June 2018 December 2018Quality Engineer 3 (Contract)Completes maintenance, organization, and distribution of technical complaint records and informationProvides support for the proper documentation of post market product complaints for medical laboratory instrumentation.Ensure prompt escalation and complete documentation of product safety complaints by requesting feedback to regional units as neededEnsure complaint documentation and records are complete and in compliance with regulatory requirements prior to closureProvide complaint handling and quality engineering expertise and consultation to significant/complex projects.Escalate incomplete or overdue complaint investigation and resolution tasks to the management of the responsible task ownerPurdue Pharma August 2017 December 2017Quality Analyst (Contract)Monitor and track to closure deviations, investigations, and CAPA for clinical trials. Perform verification of all completed action insuring proper remediation and closure. Provide management with formal status and metrics monthly.Administration of the electric documentation management system (EDMS) such as: account creation/modification, configuration activities, periodic review and verification of user access rights.Participate on project (validation and migration) to replace and globalize the document management systems.Provide Superuser support for TrackWise and document management systems, assuring the system meets business needs while meeting all regulatory requirements.Execution of GLP, clinical document submissions and Medical Affairs documentation audits in support of research activities. Perform document/submission audits to assure overall compliance, identify compliance gaps and ensure they are mitigated in a timely manner.Provide metrics to be presented at Quality Councils.Manage periodic review of regulated procedures, reporting metrics to management.Provide regulatory guidance and opinion to internal customers. Support regulatory as Backup Scribe or Response Room resource.Participate in activities related to the GxP investigation process for R&D clients.Perform other related assignments and duties as required and assigned.Experience with Documentum, Track Wise, SAP.SK Life Science February 2017 August 2017Sr. Manager, Quality AssuranceReview and approve internal SOPs, policies and guidelines and write QA SOPs.Independently lead audit planning, conduct and report on SKLSI Quality Assurance routine and non-routine audits of activities, data, internal facilities and processes in GxP to assure adherence to corporate policies, internal standards/requirements, Trial Master Files (TMFs) and compliance with applicable regulatory requirements.Support other auditors in planning, conduct and reporting of audits.Participate in regulatory inspections in core and supporting roles.Act as Subject Matter Expert / Point of Contact to provide expertise and knowledge to less experience auditors, Business Partners and the core business sector on quality and compliance processes/procedures.Maintain awareness of the regulatory and clinical research/pharmaceutical industry environment.Establish contacts with Quality professionals in the information technology, laboratory, clinical research and pharmaceutical industry.Pfizer, Inc.Compliance Consultant May 2016 February 2017Quality/Audit ManagementManage the preparation and support for inspections.Manage the tracking, preparation for and responses to internal audits.Responsible for timely follow-up of audit responses.Assess, manage and track areas of compliance risk.Develop and manage plans to achieve Vaccine Clinical Research and Development (VCRD) compliance objectives.Interface with Quality Assurance/Corporate Compliance and responsible functional areas, investigational sites, labs and vendors regarding corporate, quality and process audits. Provide progress updates to management.Responsible for coordinating responses to deficiencies found in audits by identifying root causes, developing and implementing corrective action(s) and participating in modifications to SOPs to prevent recurrence of deviations/deficiencies.Identify areas of risk in quality, compliance and inspection readiness. Develop plans to address risk with management.Analyze trends and assist in the development and implementation of preventive actions and risk mitigation strategies.SOPs/ProcessesProvide project manager expertise to develop and implement global plans for VCRD to ensure compliance with quality processes and procedural documentation.Identify and track gaps/compliance risks and develop plan to address them.Develop implementation guidelines, tasks ownership matrices and process maps for SOP implementation.Identify and maintain Subject Matter Experts (SMEs) to assist in the development and implementation of Standard Operating Procedures (SOPs) and Implementation Guidelines as they relate to VCRD.Plan/Manage projects related to the development and implementation of VCRD quality processes and procedural documentation.Training Compliance OversightCoordinate curriculum management and proactively identify roles within VCRD quality processes and procedural documentation.Identify unmet training needs and areas of opportunities.Track training compliance through reporting and follow-up.Monitor metrics and provide reports to management regarding training completion.Work with Operational Performance Strategies and other training resources to define needs and implement required training.Cardiovascular Research FoundationManager, Quality Assurance December 2009 May 2016Quality Program ManagementImplement and maintain the Cardiovascular Research Foundations quality program; promotes and facilitates continuous improvement (GCP/GLP).Develop and implement procedures for quality assurance and guide the development of Standard Operating Procedures.Train new staff on quality related SOPs and issues.Identify and resolve quality issues.Ensure compliance with Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and relevant regulatory requirements.Facilitate client/sponsor audits and regulatory inspections; leads tours, present requested documents and answer client questions (GCP/GLP).Keep up-to-date on information and technology affecting functional area(s) to increase innovation and ensure compliance.Host regulatory of health authority inspections.Auditing/InspectingSchedule and conduct QA audits for study procedures, in-phase, raw data and final reports (GCP/GLP).Review and approve equipment validation protocols and validation summary reports.Responsible for conducting facility (internal and external) inspections.Conduct project specific, system, and vendor supplier audits (GCP/GLP).Document Review and ApprovalReview protocols and Standard Operating Procedures (SOPs) for compliance with principles of GCP/GLP.Write Quality Assurance SOPs.Review all SOPs for compliance with applicable regulations.Approve the completion of CAPAs.Review and approve computer systems validations (CSV) to ensure software systems are appropriated installed, validated and Part 11 compliant, if appropriate.AdministrativeProvide reports of any deficiencies to Management and ensure resolution through CAPA system for continuous improvement.Verifiy to Management that facilities, equipment, personnel, procedures and policies are in conformance as with appropriate government regulations and industry standards.Voting member of IACUC committee at AAALAC certified facility.Perform post monitoring approval for pre-clinical studies.Perform vendor audits for pathology, toxicology and bioanalytical laboratories and animal facilities.Supervise Sr. QA Associate, Archivist and consultants.Maintain the facility Master Schedule.Provide reports of any deficiencies to Management and ensure resolution through CAPA system for continuous improvement (GCP/GLP).Verify to Management that facilities, equipment, personnel, procedures and policies are in conformance as with appropriate government regulations and industry standards.Personnel TrainingConduct training on regulatory requirements and quality initiatives (GCP/GLP).Ciba Corporation, Tarrytown, N.Y.Quality Assurance Specialist May 1996 November 2009Program ManagementDevelop and implement, Quality Assurance program, which meets cGMP (current Good Manufacturing Practices) and GLP (Good Laboratory Practices - FDA, EPA, and OECD) regulatory requirements and ISO 9001 quality standards.Maintain Quality Assurance program by keeping current on all applicable government regulations and guidance documents and implementing changes as needed.Act as host for any Regulatory Agency or Sponsor audits.Auditing/InspectingConduct external CRO GLP facility audits as necessary.Audit/inspect GLP/GMP projects to demonstrate compliance with GLP/GMP regulations - includes protocol, method of analyses, in-phase, raw data and final report inspections.Perform facility inspections for Analytical Research Services Department.Document Review and ApprovalReview and approve protocols and final reports for GMP analytical testing for medical devices.Review and approve equipment qualification plans, protocols and reports.Review and approve laboratory investigations, OOS (out-of-specifications), unusual results and deviations for GMP medical device testing.Prepare and maintain Quality Assurance Unit (QAU) SOPs and review/approve all SOPs which govern GXP activities to assure compliance with regulatory and industry standards.Monitor equipment qualifications and change control activities.Assist laboratory personnel in the determination of Part 11 compliance via risk assessment for analytical instrumentation and approve final outcome to ensure compliance.Personnel TrainingProvide GXP training for personnel involved in GXP activities.Quality Assurance AssociateProgram ManagementEnsured all quality records and standard operating procedures (SOPs) were developed, maintained, and controlled consistent with GLP/GMP compliance and ISO quality system.Wrote necessary quality assurance SOPs and assisted in the review and development of other SOPs as required to assure compliance with applicable regulations (EPA, FDA, and OECD) for GLP/GMP activities.Auditing/InspectingAudited GLP/GMP activities to demonstrate compliance with GLP/GMP regulations.Performed facility inspections for Analytical Research Services Department.Conducted external CRO facility audit when necessary.Documentation Review and ApprovalManaged all controlled documents.Reviewed and approved laboratory investigations, OOS, unusual results, and deviations for GMP activities.Writing change controls.Training PersonnelProvided GXP training for personnel involved in GXP activities.ArchivingManaged paper and chemical archives.Ensured proper archiving of test samples received for GXP studies, and inventory of primary standards.Associate Scientist II June 1990 - April 1996Analytical Laboratory TestingDeveloped analytical methods to determine drug levels in biological fluids using HPLC for GLP studies.Validated and performed analysis of drug levels in biological fluids using HPLC and Laboratory Robotics techniques under GLP and GCP standards.Determined protein binding in biological fluids.Documentation and Report WritingAssisted in the preparation of final GLP study reports.Assisted in creation of departmental SOPs.Calculated pharmacokinetic parameters and perform summary statistics.Tabulated and prepared graphs for the pharmacokinetics of drug level data.Ciba Geigy Corporation, Ardsley, N.Y.Assistant ChemistResearch/Development and Process OptimizationResearched and developed new organic fluorochemical products.Created two new cost efficient processes for the development of two industrial products.Performed organic reactions from 0.5 - 12 liter scales to optimize purity, yield, and reaction time.Performed applications of internal and external paper sizes.Formulated specific sizing for paper mill products.Technical Resource and TrainingInterfaced with customers as a technical assistant to the Sales Force.Educated Sales Force on Ciba-Geigy's fluorochemical paper sizing technology.PROFESSIONAL ORGANIZATIONSActive member of the Society of Quality Assurance (SQA)References furnished upon request. |
