Supply Chain Business Analyst

SUMMARY

QA Manager, Validation Specialist/Lead, Business Analyst, and Compliance Specialist with CSV, Pharmaceutical IT, Product & Device Manufacturing, CAR-T Manufacturing, Cleaning Validation, System Architecture, and Software QA experience with extensive experience in QA/Compliance, Testing, SQA, PM, System Software & Instrument Validation Documentation and UAT, FAT, and SAT testing and working with Regulatory Affairs, Contract Manufacturing Organization (CMO), review and approve Certificates of Assurance (CoA) and Certificates of Compliance (CoC), submissions and content management applications.

Testing experience: Consist of performing and managing the testing related to data migration, cleaning validation, Installation and Operational Qualification (IQ/OQ), System Integration Testing (SIT) and User Acceptance Testing (UAT) on various Pharmaceutical applications/systems e.g.; LIMS, Star LIMS Labware ELN, CTMS, CAPA, CRM/financial, ERP, SAP manufacturing, MPM, PDM, training applications/LMS systems for COTS and In-house systems and instrument qualification, validation, calibration, commissioning and decommissioning of various lab equipment, Drug Supply Chain, Security and eQMS (Electronic Quality Management System) for J&J, BMS, Merck, Sanofi and ImClone.

Experienced in developing various clinical, manufacturing, Asset Management, Maximo, CAPA, CRM, ERP, MES, PLM SAP, Pharmacovigilance, Labeling & Packaging Systems Supply Chain systems, various SAP modules such as the (QM), (TM), (GDP) (PLM), (MM), (PM) (MDM), SAP S/4HANA, SAP Environment Health Safety (EHS), Laboratory Equipment qualification, Veeva Vault, eQMS, RIM, CRM, Connector, remediation of various IT, manufacturing, clinical, labeling and package & CRM systems, test approaches, System, Functional and User Requirement & Configuration Spec’s, Val Plan’s, GxP Assessments, Risk Assessments, test protocols, (IQ OQ, PQ,) SIT and UAT test scripts/test cases, Summary Reports, Medra, E2B reports, RTM’s, operational and maintenance SOP's, Serialization Master Data (SMD) Specifications, Serialization Requirements, developing workflows, process maps, application and administration SOP’s, Data Management and Data Migration spec’s, provided support during Hypercare period, Electronic Common Technical Documents (eCTD) submissions for submitting applications, amendments, supplements, and reports to FDA's Center for Drug Evaluation and Research, Activity & Support Diagrams, validation and testing of clinical trial systems / (discovery/diagnostics drug testing), dilution system testing, critical reagents testing, familiar with cell gene therapy CSV, supply Chain validation and initiating change controls for implementation of new systems and instrumentations. Carry out dry runs for system development and to weed out possible requirement, script or test errors prior to formal execution. Extensive experience with Argus safety database and PV Operations, including configuration, reporting, support and maintenance.

Experienced in ensuring manufacturing complies with applicable procedures, reviewing and approving batch records, product labeling and packaging, reviewing of various manufacturing/shop documentation, cleaning validation involving biologics and authoring, reviewing, executing and approving cleaning validation documentation, involving Sampling Plans, Acceptance Criteria Determinations reviewing and analyzing data, interfacing with Quality, and review investigations, interpret results and generate technical conclusions.

Laboratory Instrument Qualification/Lab Equipment validation experience: Consists of validating UV/Vis spectrophotometer instrument systems, Plate readers, chromatography instruments such as HPLC, UPLC and GC Gas Chromatograph instrument systems. Mass Spectrometers, Nicolet FTIR 4700 & 6700, Mixing Stations, Isolators, Bioreactors, Fume Hoods, Agilent UV-Vis ChemStations, that feed data to various Laboratory Information Management Systems that I validated such as Watson LIMS, LIMS Sample Manager and Water's Empower. I performed Electronic Laboratory Notebook (ELN) validation used on various LIMS and Water's Empower systems and validated Electronic Experiments (eE) and laboratory templates.

Labeling/Packaging experience: Consists of creating labels in SPL and PLR format and verifying and ensuring the integrity of these product labels were compliant with PDMA to minimize the risk of recalls due to misbranding and potential subsequent regulatory citations.

IT/QA Management experience: Consists of managing CAPAs, developing processes, flows and authoring guidelines to support role base training plans, internal and external audits and inspections in an IT environment. Managed the development/revision and reviews of various documentation, forms and templates in Veeva Vault, Documentum, FirstDoc and Pilgrim for LIMS, Labware ELN, CTMS, CAPA, CRM, financial, ERP, MES, training/Learning Management Systems, (ComplianceWire), COTS and In-house systems. Managing the validation, compliance, implementation writing, reviewing and approving of validation documentation. Involved in execution of software, installation of hardware, qualification of infrastructure and resolving testing and compliance issues on various projects for Sanofi, Merck, J & J, Warner Chilcott, Imclone Systems, BMS, ICON and Systech International. Quality Management System ISO9000, Compliance Quest, Total Quality Management (tQM).

IT/QA Compliance Management experience: Consists of managing various projects involving applications ranging from MES, ERP, CTMS, PLM, CRM, LIMS, CAPA’s, Pharmacovigilance and Drug Supply Chain systems and handling of deviations, Non-conformance process issues related to these applications. Working with the following FDA standards, cGMP, GDP,GCP, GLP, CBER, GAMP4 & 5, HIPAA, PDMA, EMEA, Drug Supply Chain Security Act (DSCSA), Drug Quality and Security Act (DQSA)1, National Drug Code (NDC), Council for International Organizations of Medical Sciences (CIOMS), ICH, ASTM E2500, e-Pedigree (an electronic document which provides data on the history of a specific batch of a drug which satisfies the requirement for a drug pedigree), European Union Medical Device Regulations and International Serialization regulations. Involved in audits and inspections, identifying regulatory/compliance issues involving new & existing computer systems and software involving, CAPA, security, clinical trial, financial, product sampling, labeling, packaging, manufacturing systems, HA submissions. Administering/managing of Quality Assurance projects involving various validation documentation, procedures, testing and training documentation.

Business Analyst experience: Consists of writing business workflow processes and translating them into Business, Functional and User Requirements, User Stories and SOP’s. Act as the key liaison between the business owner and technical team to architect solutions in finalizing Business, Functional and User Requirements, testing strategies and gain system approval of Labeling, Financial, Information Management, Resource, Manufacturing, Pharmacovigilance, Biopharma, CTMS, CRM, LIMS, eQMS, HR, Data Management, Oracle and Clinical and Nonclinical R&D systems.

Proficient in analyzing a systems Business, Functional and User requirements, implementation and process improvements in a Clinical and Nonclinical R&D environment for Bio-Pharmaceutical domain, Medical Devices, and Supplier Management processes for compliance with EU MDR regulations.

Proficient in Business, Functional and User requirement gathering and performing requirement analysis using Blueprint and CaliberRM tool.

Experienced with Business Process Modeling and Data Modeling for clinical and nonclinical R&D systems

Drug Supply Chain experience: Consists of managing the validation testing and implementation of SAP SCM 7.0 a Drug Supply Chain system at Amgen & Merck. The Supply Chain functions involved the purchasing, manufacturing, warehousing, transportation, customer service, demand planning, supply planning and Supply Chain management. Methodology, followed the four 4 main elements of Supply Chain Management, Integration, Operations, Purchasing and Distribution to be cost-effective and competitive and adhered to the Drug Supply Chain Security Act (DSCSA) and corporate standards and policies.

System Development Life Cycle (SDLC) experience: Consists of managing each phase of the SDLC process and verifying that all applicable SDLC documentation and testing has been completed and approved before releasing an application into a production environment.

IT Infrastructure Library (ITIL) experience: Consists of following, documenting and managing ITIL lifecycle model; Service Strategy, Service Design (models for productive operation), Service Transition (service implementation/launch), Service Operation (productive operation of services) and Continual Services Improvement guideline that all define how to plan, deliver and support IT service features.

Technical Writing experience: Consists of creating and updating SOP’s involving software, hardware, product sampling, manufacturing, lab instruments, various manufacturing equipment, receiving, product handling, calibration, operation and preventive maintenance plans, validation documentation such as; Validation Plans, Test Protocol Plans, Project Charters, Quality Plans, System & Integration Plans, Data Conversion Plans, SRS’s, URS’s, FRS’s, SDS’s, RTM’s, FAT’s, SAT’s, SIT's, UAT’s, and Summary Reports. Created/updated User Stories, Acceptance Criteria's, manuals involving User Software, System & Security Administration, Help Desk, Electro/Mechanical drawings and specifications related to lab and manufacturing equipment, construction, HVAC, Parts Illustrated, Assembly, Installation, Maintenance/Service & Operating manuals. Other types of documentation involved programming standards, process guidelines, policies, test equipment, training material, guides, retirement documentation, forms and brochures.

Achievements:. Successfully achieved validation/production approval of the following applications/systems:

Amgen - ALM v15.5, Siebel CTMS Clinical Trial Management System, Veeva Vault QMS, RIM, CRM, Connector, ARISg & Argus a TrackWise, Pharmacovigilance Safety application, MES, ERP, LIMS, SAP Solution Manager and various other modules such as (QM), (MM) & (PLM), SAP SCM. 8.8. 6.7 Drug Supply Chain Systems like SAP S/4HANA, Labeling & Packaging Systems, Maximo, PeopleSoft, CAR-T Manufacturing, recently Validate & Implemented Veeva Quality Management System (QMS) and currently using Veeva QMS and provide oversight to ensure various computerized systems are deployed and following the Lifecycle Management mythology, SDLC, and making sure all systems remain in a validated state by following SDLC, IT mythology. Currently Using Veea QMS to writing, reviewing and approving Change Controls, Deviations and various documentation e.g. Design, Requirement & Configuration Specifications, Validation Plans Test Protocol Plans, Test Scripts. Traceability Matrix, Summary Reports, SOP's etc. per associated regulatory and security requirements. Currently providing QA support for optimizing, troubleshooting, and maintaining key global GMP quality systems including Veeva Quality Docs (electronic document management system) and additional GxP systems for Gene Therapy manufacturing and other type of product manufacturing and for other system e.g., LIMS, SAP, Supply Chain, Pharmacovigilance, Biopharma, CTMS, CRM, LIMS, eQMS, HR, Data Management, Oracle and Clinical and Nonclinical R&D systems.

Merck – Watson LIMS v7.6.1, Spectrum 4.0 an Oracle based Siebel Clinical Trail Management System, Trackwise, istudyReporter, SAP S/4HANA, SAP Manufacturing and modules (QM), (PLM), (MM), (PM) (MDM) SAP SCM. 8.8. 6.7 Drug Supply Chain.

Sharp Packaging – Systech, labeling and package line automated software system.

Sanofi – Watson LIMS v7.5, a clinical data management system used to create/design (PK, TK, PD) clinical and nonclinical studies. (CAPA project), LMS, SharePoint, SAP R/3, SAP S/4HANA, ARISg & Argus a Pharmacovigilance Safety, cleaning validation.

J&J – Siebel CTMS Clinical Trial Management System & CRM applications involving SalesForce, Siebel, Managed Marks, Territorial Management and Customer Call Center interfaces, SharePoint, eTMF, PLM, SAP Manufacturing and modules (PLM), (EHS), (MD), (QM), (MM), (PP),(PS), (PM) & (SD) Solution Manager, Master Data, Financial module, Argus 7.5 Pharmacovigilance Safety System and LMS application.

Schering-Plough – Prosit, a clinical data management system for entering and tracking clinical trials/studies.

Pfizer – Validation and production approval of various production servers & software.

Schindler Elevator – achieved ISO 9000 certification.

BMS – Maximo, LIMS Sample Manager, Empower, LMS, TrackWise, PLM SAP Manufacturing and the following modules (PLM), (EHS), (MD), (QM), (MM), (PP),(PS), (PI), (PM) & (SD).

Systech International – Inspection/Vision Solution & Labeling & Packaging System.

ICON – ARISg & Argus a Pharmacovigilance Safety System that tracks, processes, and reports on Adverse Events.

ImClone – Watson LIMS, a clinical data management system used to create/design (PK, TK, PD) clinical and nonclinical studies, Argus 6.0 Pharmacovigilance Safety System, CAPA's

Warner Chilcott – TrackWise v8.4.1, Argus 6.0 a Pharmacovigilance Safety System and CAPA's

STANDARDS

Familiar with FDA standards: 21CFR Part11, 58, 99, 111.27(d), 160, 201, 203, 207, 210, 211, 211.67(d), (211.122(g) 125, 130, 132,134, 137), 198, 314.80, 803, 806, 820 & 820.70(e) 21 CFR 211.67(a), 21 CFR 820.30, 21CRFR1271, ISA S88 & 95, IEC 62304, ISA95 standard, GAMP5, GMP, cGMP, GCP, GLP, QSR 21, MDD. ISO9000, ISO9001, ISO13485, ISO19227, ISO14971, ISO 27001, & ISO 17025:2017, CSV, SOX 302,404, HIPAA, PDMA, ASTM E2500, ICH, Q8, Q9 & Q10, xEVMPD, IDMP, H R 3204 Drug Quality & Security Act, Prescription Drug User Fee Act (PDUFA III), Drug Quality and Security Act (DQSA)1, IEC 62304, 62443, 62443-4-1, 62443-4-2, 62443-3-3 and IEC 60601-1 Medical Device Marking and Labeling standard, ISO 14791 European Union Medical Device Regulations (EU MDR), Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC) Regulatory Submission, ISO 15223-1:2012 Medical devices Symbol standard, Drug Code (NDC), Identification of Medicinal Products (IDMP), eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), HL7 standards, ISOISP standards, Electronic Submission Regulation (EC) No. 726/2004 Article 57(2), second subparagraph, Drug Supply Chain Security Act (DSCSA), ANSI/HL7 V3 SPL, R4-2009, ICH M2 EWG

DATABASE, OPERATING SYSTEM, WEB & SOFTWARE EXPERIENCE

Databases: Oracle, UNIX.

Operating Systems & Web Environments: Windows XP, MS Windows 07, Windows NT 4.0, Mac 7.1, Explorer & AOL.

Software: Watson LIMS 7.4.1, 7.5, & 7.6.1 Maximo 6.2, ARISg 5.0.2, Argus 5.0,6.0, 7.0, 8.0, 8.1, Siebel 7.8-8.1 LIMS Sample Manager 2004, Labware ELN, TrackWise 6.0, 7.0 & 8.0, e Doc, Documentum D2, 6.5 & 7.0, Veeva Vault 21R3.1, Training/Learning Management Systems, (ComplianceWire), Kallik’s Artwork Management Solution (AMS), GxPharma, SAP R/3 & ECC6 Systems, PLM, SAP’s (PLM), (EHS), (QM), (TM), (GDP), and Solution Manage modules, PeopleSoft, Remedy 5.0, Analyst, Empower, Chemstation, Xcalibur, Six Sigma, AS/400, Word, MS Office, Excel, Access, PowerPoint, MS Project, Outlook, Visio, D2LMS, SharePoint Records & Document Management System, Application Lifecycle Management (ALM) 11.5 & 15.5, Pilgrim, Salesforce, MS Dynamics, Oracle v11.2.0.3.0 and Oracle E-Business Suite v12, Spectrum 4.0, SharePoint, TrackWise, Veeva Vault, Veeva CRM, Veeva RIM, SAP SCM 7.0, SAP S4/HANA, eQMS (Electronic Quality Management System)

SoftwareTools: HP Quality Center & ALM, SharePoint, ETQ, SQL, Quick Test Pro, LoadRunner, Blueprint and CaliberRM

PROFESSIONAL EXPERIENCE:

Commonwealth of PA - Harrisburg PA 04-24 to Present

Business Analyst / Validation Specialist (Consultant)

Responsible for documenting current business workflow processes and translating them into Business, Functional and User Requirements to understand the current needs for a new LIMS system. Involved in developing the possible testing strategy/approach for the LIMS application. Recommended SDLC risk base approach/methodology to be followed to archive production approval of a new LIMS application.

Worked with business owners, and technical team to help manage the project, write, review and approve Business, Functional and User Requirements, Configuration Spec, developed workflows and process maps.

Other responsibilities involved, verifying that the LIMS application will be compliant with state and FDA regulatiions, clinical research and analysis for business improvement and future business needs for a LIMS application to perform Clinical Trials on various live stock .

Amgen Thousand Oaks CA 10-20 to Present

QA Manager / Compliance Specialist / Validation Specialist / BA (Consultant)

Supporting and managing the Validation, Remediation, Architecture and Qualification of various computerized systems such as LIMS, ALM 15.5, Pharmacovigilance Systems, Salesforce, PeopleSoft, Veeva Vault RIM, CRM, SAP S/4HANA SAP PLM, QM, TM, GDP, MM, Quality Management System (QMS), TrackWise, PeopleSoft, Asset Management, Maximo, ComplianceWire a Learning Management System, and electronic trial master files (eTMF), Clinical Trail Management Systems (CTMS), SAP, ERP, Star LIMS, Labeling & Packaging Systems involving labeling & serialization, of products, medical devices, Salesforce, Supply Chain Systems, Manufacturing Systems (MES), cleaning validation involving biologics, authoring, reviewing, and approving validation documentation, analyzing data, Sampling Plans, Acceptance Criteria Determinations, investigations, interpret results and generating technical conclusions and reviewing and approving batch records. Lab instrument stations consisting of various types of analytical and bio-analytical instruments in a GMP and non-GMP environment, supporting periodic review effort on past validations and CAPA's and IT support. Currently using TrackWise to create and approve Change Controls, verify QA status on various projects related to Implementation, documentation, Assessments, execution, deployment etc. Extensive experience with Argus safety database and PV Operations, including configuration, reporting, support and maintenance and SharePoint experience, Contract Manufacturing Organization (CMO), review and approve Certificates of Assurance (CoA) and Certificates of Compliance (CoC).

As the QA Compliance Specialist and Validation Specialist/Lead I am involved in contributing to performing dry run testing, writing, reviewing and approving of Requirement Specifications, Validation Plans, IO, OQ PQ and UAT Test Protocol Plans, Traceability Matrices, Summary Reports, Technical Recovery Plans, System Retirement Plans and Training documents related to the validation and qualification of computerized systems and lab instruments. Adhering to various regulations e.g.; GAMP5, GxP, GMP, cGMP, GCP, GLP, QSR 21, MDD. ISO 19227, 13485, 14971, 9001, 27001, & ISO 17025:2017, IEC 62304, 21 CFR 820.30, 21CFR Part11, 21 CFR 211.67(a), CMC Regulatory Submission, Veeva Vault, eQMS, RIM, CRM, Connector, EU MDR, SOX, and working with Regulatory Affairs, submissions and content management applications.. Managing vendor's, involving audits, documentation, pre & post testing, CRO's and clean validation.

Involved in performing pre and post review of IQ, OQ, PQ and UAT testing, documenting and resolving defects, writing, reviewing and approving various documentation in Veeva Vault QMS. Veeva CRM and Salesforce a Customer Relationship Management application that handles account management, primary care, pharmacy sales, field medical tasks, and coordinators events. Involved in approving Change Controls using TrackWise and ServiceNow for IT Change Management and working with Veeva RIM a Regulatory Information Management System used to manage product, registration, document submissions, archiving and health authority correspondences and commitments.

MERCK Rahway NJ 10-19 to 04-21

Business Analyst / QA / Validation Specialist / Compliance Specialist (Consultant)

Supported and managed various projects as the Validation Specialist and Business Analyst gathering and developing Requirement Specifications, Process Workflow Diagrams, Risk Assessments, Validation, Remediation and Qualification of various computerized systems and lab instrument stations consisting of various types of analytical and bio-analytical instruments in a GMP and non-GMP lab environment, supported and validated the eQMS (Electronic Quality Management System), TrackWise, involved in periodic reviews and CAPA's efforts on past validations and IT support. Adhering to various regulations e.g.; GAMP5, GxP, GMP, cGMP, GCP, GLP, SOX, QSR 21, MDD, ISO 13485, & 9001, 21CFR Part11, work with Regulatory Affairs, submissions and content management applications. Managing vendor's, involving audits, documentation, pre & post testing and CRO's and Cleaning validation.

As the Validation Specialist/Lead and Business Analyst I am involved in contributing to the dry run testing, writing, reviewing and approving of Requirement Specifications, Validation Plans, IOQ and UAT Test Protocol Plans, Traceability Matrices, Summary Reports, Technical Recovery Plans, System Retirement Plans and Training documents related to the validation and qualification of computerized lab instruments.

Involved in performing IOQ and UAT dry run testing, pre and post review of IOQ and UAT testing, documenting and resolving defects, writing, reviewing and approving Change Controls and corrective action approvals of defects.

Also involved in the validation upgrade of Watson LIMS v7.4.1 to v7.6.1, istudyReporter, ELN, SAP S/4HANA and the following modules, Finance (FI), Controlling (CO), Sales and Distribution (SD), Material Management (MM), Production Planning (PP), Material requirement planning (MRP), Quality Management (QM), Plant Maintenance (PM), Project System, (PS), Product Lifecycle Management (PLM), Environment, Health, and Safety (EHS), Master Data Management (MDM), Verification of the Validation and archiving of Trial Master Files (eTMF), Veeva Vault eQMS, RIM, CRM.

Windows 7 to Windows 10 upgrade on various computerized instrument stations and PLM a Product data platform. Tasks involve evaluating if instrument software is compatible with Windows 10, contacting vendor to verify if they have software that is compatible with Windows 10, installation of Window 10 software, Maximo and validation and requalification of instrument stations.

SHARP PACKAGING Allentown PA 7-18 to 7 19

Quality Assurance / Validation Expert (Consultant)

Supporting and managing the Quality Assurance and Validation/remediation of the labeling, serialization, inspection, and equipment and software qualification of computerized labeling and packaging and automated equipment systems for various pharmaceutical products in a GxP environment and supply Chain validation. Adhering to cleaning and manufacturing regulations/standards e.g.; GMP, cGMP, ISO 9001, 19227, 21CFR Part11, 21 CFR 211.67(a) EU MDR.

As the Quality Assurance and Validation Expert I am involved in contributing to the testing, writing, reviewing and approving of Serialization Master Data (SMD) specifications, plans and Requirement Specifications, Validation Plans, Testing Strategies, IOQ and UAT Test Cases, Traceability Matrices, Summary Reports, Serialization Plans, Technical Recovery Plans, System Retirement Plans and Training documents related to the validation and qualification of computerized labeling and packaging and automated equipment systems for various pharmaceutical products for Sharp Labeling and Packaging. Managed vendor's involving audits documentation, pre & post testing and CRO's.

Involved in performing IOQ and UAT testing, pre and post review of IOQ and UAT testing, documenting and resolving defects, writing, reviewing and approving Change Controls and quality agreements. Currently using Pilgrim for pre and post reviews for approving various documentation involving IOQ and UAT executions and for tracking corrective action and approvals of defects.

SANOFI, Bridgewater NJ 5-17 to 6-18

Quality Assurance / Validation Expert / Business Analyst (Consultant)

Supported and managed the Quality Assurance and Validation/ remediation of various software applications and data migrations that were GxP and Non-GxP related projects per SANOFI’s PUMPA methodology. Supported the review and corrective action of CAPA's, performed Periodic Reviews on various projects involving reviewing all types SDLC/PUMA documentation and discovery/diagnostics drug/cell gene therapy, CMC Regulatory Submissions, CSV testing and validation of Veeva Vault eQMS, RIM, CRM. Contract Manufacturing Organization (CMO), review and approve Certificates of Assurance (CoA) and Certificates of Compliance (CoC).

As the Business Analyst, Quality Assurance and Validation Expert I was involved in contributing to the testing, writing and approving of Requirement Specifications, Validation Plans, Architecture and Configuration Spec's, develop workflows, process maps, Data Migration Plans, Technical Recovery Plans (TRP’s), System Retirement Plans, Testing Strategies, Test Cases, Traceability Matrices, Training documents, Authorization of Use, System Integration Test Designs, User Acceptance Testing Designs, SIT and UAT Test Cases and, various reports.

Installation Qualification Reports (IQR), Data Migration Reports (DMR), SIT, UAT and Final Validation Reports for various applications e.g.; Watson LIMS, Labware ELN a Clinical Data Management System, PeopleSoft, ARISg & Argus a Pharmacovigilance Safety System, SAP R/3, SAP S/4HANA, eDoc, FirstDoc and Documentum a Doc Management System, worked on Sanofi's Learning Management System (LMS) and instrument qualification, validation, calibration, commissioning and decommissioning verification and initiating change controls, writing and updating User Requirements, protocols, reports, operational and preventive maintenance SOP's related to various lab equipment, cleaning and validation documentation, analyzing data, Sampling Plans, investigations, interpret and results generating technical conclusions.

MERCK, Rahway NJ 3-16 to 1-17

Business Analyst / Validation Specialist / QA Compliance Specialist (Consultant)

GUARDIAN, Bethlehem, PA 6-15 to 3-16

Business Analyst / Validation Specialist /QA Compliance Specialist (Consultant)

TELERX, Horsham, PA 10-14 to 12-14

Business Analyst / QA Compliance Specialist (worked as a Consultant)

inVentiv Health, Somerset, NJ 6-14 to 8-14

Validation Specialist / Business Analyst / QA Compliance Specialist (Consultant)

JOHNSON & JOHNSON, Skillman & Somerville NJ & Fort Washington, PA 10-13 to 4-14

Validation Specialist / Business Analyst / QA Compliance Specialist (Consultant)

WARNER CHILCOTT (US), LLC, Rockaway, New Jersey 5-13 to 10-13

Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant)

IMCLONE SYSTEMS, Branchburg, New Jersey 3-12 to 4-13

Validation Specialist / Business Analyst QA Compliance Specialist (Consultant)

FOREST LABS, Jersey City, New Jersey 9-11 to 11-11

Validation Specialist / Business Analyst (Consultant)

MEDIMEDIA, Yardley, PA 3-11 to 8-11

Validation Specialist / Business Analyst / QA Compliance Specialist (Consultant)

PFIZER INCORPORATED, Collegeville, PA 12-10 to 2-11

Business Analyst (Consultant)

JOHNSON & JOHNSON, Raritan, New Jersey 5-10 to 10-10

Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant)

IMCLONE SYSTEMS, Branchburg, New Jersey 6-09 to 4-10

Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant)

BRISTOL MYERS SQUIBB CORPORATION, New Brunswick, New Jersey 7-08 to 5-09

Validation Specialist / Business Analyst / IT/QA Compliance Specialist (Consultant)

ICON CLINICAL RESEARCH, North Wales, PA 10-07 to 7-08

SQA Manager Engineer Level III (Consultant)

BRISTOL MYERS SQUIBB CORPORATION, New Brunswick, New Jersey 4-07 to 9-07

Validation Specialist (Consultant)

JANSSEN PHARMACEUTICAL, Titusville, New Jersey 2-06 to 3-07

QA / Validation Manager (Consultant)

SYSTECH INTERNATIONAL, Cranbury, New Jersey 6-04 to 1-06

SQA & Documentation Manager

SCHERING-PLOUGH CORPORATION, Kenilworth, New Jersey 6-03 to 6-04

Validation / Compliance Specialist (Consultant)

PFIZER INCORPORATED, Morris Plains, New Jersey 4-03 to 6-03

Validation / Compliance Specialist (Consultant)

SCHERING-PLOUGH CORPORATION, Kenilworth, New Jersey 10-02 to 3-03

Validation / Compliance Specialist (worked as a Consultant)

BRISTOL MYERS SQUIBB CORPORATION, Princeton, New Jersey 4-02 to 9-02

Validation Specialist (Consultant)

EDUCATION: New Jersey Institute of Technology: Electrical Engineering Technology Degree

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