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Click here or scroll down to respond to this candidate207 Le Carra DriveLansdowne, PA Street Address
PHONE NUMBER AVAILABLE HomePHONE NUMBER AVAILABLE CellCandidate's Name
E-Mail: EMAIL AVAILABLESUMMARY of QUALIFICATIONSBiopharmaceutical experience with excellent interpersonal and communication skills. Specific strengths include CAPA analysis, compliance audits, batch record, batch release and standard operation procedure review and manufacturing support.CAREER HIGHLIGHTSMerck, West Point, PA 2020-PresentSenior Quality Assurance Specialist - External Systems CoEPromoting the development, implementation, maintenance, and enhancement of critical processes, systems and master data such as COMET SAP, Supplier Transparency, Remedy, Global Change Management (GCM) Trackwise,Collaboration sites and Integrated Product Information (IPI).Compiling, evaluating, and reporting associated metrics.Functioning objectively and/or within a team setting showing influence to facilitate enhancement of existing business processes and systems and identify and advance performance improvement activities.Promoting the development and implementation of strategic projects assuring compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations Good Manufacturing Practice (GMP), etc., both domestic and foreign.Maintains and provides expertise on ExN systems, tools, data, and processes on an ongoing basis, specifically COMET SAP via the use of specific T-Codes in COMET SAP- including the troubleshooting of SAP issues and the building of new materials in SAP to promote the ExN supply chain.Provide ongoing systems Subject Matter Expert (SME) support ensuring ExN data and processes run smoothly with no interruption to supply for SAP, Ariba and IPI.Establish new or improved processes, tools, and systems and drive consistent, standard business processes across External Quality Organization (EQA).Serve as the SME for IT project development and implementation within ExN.Accountable, as needed, for serving on teams when IT and Business systems representation is needed related to any systems, data, or processes in relevant areas.Assist in workload management for ExN Systems CoE COMET SME team.Assist in the preparation, coordination, and delivery of Senior Management presentations.Operate in a safe and efficient manner and in compliance with the Manufacturing Division Quality Operations (QO) Safety and Health PolicyMerck, West Point, PA 2017-PresentQuality Specialist- Packaging Operations (non-aseptic processing)Performs packaging batch release for vaccine final package.Collaborates with Planning, Operations and Technology organizations to ensure batches release by target due date.Assists in sending samples and lab reagents to regulatory agencies.Completes required SAP transactions for Batch record review and product release in SAP.Complete reviews and submit release batch release protocols to regulatory agencies.Performs 100% audit of process documents, logbooks and elogs to ensure completeness and accuracy for Packaging department.Prioritizes and tracks batch record and protocol review to ensure alignment with batch release target due dates.Provides coaching and mentoring of manufacturing personnel to discuss and resolve completion of GMP documentation.Certified Shop Floor Auditor- performs GMP walk- through inspections, within Packaging operation department, to ensure compliance with GMP and regulatory requirements.Ensures proper identification of release status and control of materials through maintenance of quarantines in SAP and through physical tagging of material as required.Performs Quality review and approval of new and updated SOPs and CJAs.Assists with training of incoming quality personnel and ensures compliance with departmental procedures.Actively participates in the Tier process and uses this forum to escalate concerns and best practices while collaborating with Packaging operation team members in the identification and implementation of continuous improvement initiatives and action plans.Performs Quality review of new and updated Master Batch Records and approves Emergency batch record stamps.Collaborates with Packaging Operation team members to investigate deviations on the production floor.Approver of all process changes, via the change request approval process, utilizing the Trackwise application.Trained to provide support of RMT for all agency inspections for West Point packaging operations.Merck, West Point, PA 2012-2017Quality Associate Specialist- Sterile Packaging Operations (aseptic processing)Performed batch record review for vaccines lyopholization and inspections.Provided direct quality support to ensure all areas are in compliance with federal regulation and to ensure activities are completed according to Standard Operating Procedures (SOP).Communicated and worked closely with integrated process team to ensure adherence to batch review cycle times and CBER submission datesTrained and gained competency in activities to facilitate production batch release.Collaborated with production team members to identify and implement continuous improvement initiatives and action plans thus delivering right first- time manufacturing documentation. (Merck Six Sigma Yellow Belt Certification)Participated in Tier process and uses forum to coach and mentor manufacturing operators and communicate best practices.Performed real-time shop floor GMP audits to ensure shop floor compliance while collaborating with Operations, Technology and Planning personnel to resolve issues, support investigation completion and provide quality recommendations and corrective actionsPerformed 100% process GMP document and logbook audits for accuracy and completeness.Reviewed of environmental testing associated with batch manufactureReviewed and approved Manufacturing process SOPsIssued manufacturing document for use on shop floorCertified shop floor auditor- conducts monthly shop-floor aseptic and non-aseptic audit.Johnson& Johnson-Centocor Inc, Malvern, PA 2005-2012Associate BiotechnicianPerformed vial thaws and scale up of subcultures to initiate new batches for 110 / 1000L bioreactors.Responsible for performing aseptic manipulations under a biological safety cabinet.Troubleshot slow cell growth sessions, predicting vial thaws for inconsistent production schedules.Trended and recorded data, log activities, monitor processes and troubleshoot equipment.Communicated status of operations in a timely manner to management including any safety or maintenance issues while conducting department safety Den Meetings.Revised SOPs perform batch record reviews; participate in internal audits, and error-proofing projects.Trained new associates on cell culture and fed batch proceduresPerformed CIPS, SIPs, assembly and inactivation procedures on bioreactors while complying with GMP requirements and safety procedures.Participated in 5S organizational projects for streamlining and performance improvement.EducationUniversity of Maryland Eastern Shore, Princess Anne, MDBS in Biology/ Agricultural ScienceDrexel University, Philadelphia, PAGraduate Course Work in Physician AssistantAWARDS AND HONORSAlliance Minority Participation Honors ScholarshipPennsylvania Literacy CorpsComputer SkillsLIMS, SAP,MES, DeltaV web, SCADA, Track wise, Midas, Analytical Instrumentation, Word, Excel, and PowerPoint |
