SUMMARY

QA, Validation Specialist/Lead, Business Analyst, and Compliance Specialist with CSV, Pharmaceutical IT, Manufacturing, Cleaning Validation and Software QA experience with extensive experience in QA/Compliance, Testing, SQA, PM, System Software & Instrument Validation and Documentation.

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, 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, CAPA, CRM, ERP, MES, PLM SAP, Pharmacovigilance, Labeling & Packaging Systems Supply Chain systems like SAP S/4HANA and Laboratory Equipment qualification, Veeva eQMS, RIM, CRM, 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, 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, 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 applications/ Learning Management Systems for 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.

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, ARISg & Argus a Pharmacovigilance Safety, 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, eQMS (Electronic Quality Management System).

Merck – Watson LIMS v7.6.1, Spectrum 4.0 an Oracle based Siebel Clinical Trail Management System, istudyReporter, SAP Manufacturing and modules (QM), (PLM), (MM), (PM) (MD) 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, 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), ISA S88 & 95, ISA95 standard, GAMP5, GMP, cGMP, GCP, GLP, QSR 21, MDD. ISO 19227, 13485, 14971 & 9001 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 62443, 62443-4-1, 62443-4-2, 62443-3-3 and IEC 60601-1 Medical Device Marking and Labeling standard, European Union Medical Device Regulations (EU MDR), Pharmaceutical Quality/CMC, ISO 15223-1:2012 Medical devices Symbol standard, Drug Code (NDC), Identification of Medicinal Products (IDMP), eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), HL7 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, Kallik’s Artwork Management Solution (AMS), GxPharma, SAP R/3 & ECC6 Systems, PLM, SAP’s (PLM), (EHS), (QM) 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:

Amgen Thousand Oaks CA 10-20 to Present

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

Supporting and managing the Validation, remediation and Qualification of various computerized systems such as LIMS, ALM 15.5, Pharmacovigilance Systems, Salesforce, PeopleSoft, Veeva Vault RIM, CRM, SAP PLM, QM, MM, eQMS (Electronic Quality Management System), Maximo, Learning management, and electronic trial master files (eTMF), Clinical Trail Management Systems (CTMS), SAP, ERP, 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.

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, 21CFR Part11, 21 CFR 211.67(a), EU MDR, SOX, and a lot more. 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

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

Supporting and managing the Validation, remediation and Qualification of computerized systems and lab instrument stations consisting of various types of analytical and bio-analytical instruments in a GMP and non-GMP lab environment, supporting periodic review effort on past validations and CAPA's and IT support. Adhering to various regulations e.g.; GAMP5, GxP, GMP, cGMP, GCP, GLP, SOX, QSR 21, MDD, ISO 13485, 9001, & 19227, 21CFR Part11, 21 CFR 211.67(a) EU MDR. Managed vendor's, involving audits, documentation, pre & post testing, CRO's and clean 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 Manufacturing and the following modules (PLM), (EHS), (MD), (QM), (MM), (PP),(PS), (PI), (PM) & (SD), 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 (VEX) / 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 CSV testing and validation of Veeva Vault eQMS, RIM, CRM.

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, ARISg & Argus a Pharmacovigilance Safety System, 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 for the systems mention above, cleaning validation authoring, reviewing, and approving validation documentation, analyzing data, Sampling Plans, Acceptance Criteria Determinations, investigations, interpret results and generating technical conclusions.

Involved in pre and post reviews of SIT, UAT and Migration Test Case executions, defects and writing, reviewing and initialing and approving Change Controls, Risk Assessments, quality agreements, validation and archiving of Trial Master Files (eTMF) and monitoring SIT and UAT testing. Tracked the corrections and approvals of defects using Application Lifecycle Management (ALM), Serves Now, e Doc and First Doc for documentation.

MERCK, Rahway NJ 3-16 to 1-17

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

Responsible for handling Business Analyst tasks and managing/supporting the validation/remediation effort for Spectrum 4.0 an Oracle based Siebel Clinical Trail Management System (CTMS) SAP’s (QM), Labware, ELN and PLM a Product data platform. Business Analyst tasks involve gathering requirements, updating and approving Requirements & Configuration Specifications, developing workflows, process maps, pre and post reviews and approvals of test scripts, investigation and closure of defects and data analysis. SDLC risk base approach computer validation methodology was being followed for this project. Other tasks involved calibration, commissioning and decommissioning on various laboratory equipment for Spectrum a CTMS system and validation of Veeva Vault QMS, RIM, CRM and reviewing and approving batch records. Adhering to various regulations e.g.; GAMP5, GMP, cGMP, GCP, GLP, QSR 21, MDD. ISO 13485, 14971 & 9001, 21CFR Part11, and a lot more.

Involved in system change control reviews and approvals, risk assessments, coordinating and performing execution/qualification of infrastructure, application, management of CAPAs, support internal audits related, data Migration for UAT testing and ensured Spectrum application was compliant with internal company policies, procedures and compliant with GCL and 21CFR Part 11 regulatory regulations.

Managed offshore testing team of 5 people for CSV team that involved pre and post review and approval of test scripts, test defects and testing of Spectrum 4.0. Used Application Lifecycle Management (ALM) for pre and post reviews, for SIT and UAT executions and tracking of defects and managed the development/revision and reviews of various specs, procedures, forms and templates related to clinical trials.

Supported and managed the Quality Assurance of various validations involving products discovery/diagnostics drug testing), dilution system testing and training documentation that supported our training plans. Updated and generated new training material e.g.; user guides, job aides and author guidelines, ensuring our training plans were updated in our Learning Management System and managed the development/revision and reviews of various documentation, forms and templates all related to clinical trials. Tracked execution of pre and post reviews and approvals of test scripts, investigation and closure of test defects encountered during testing. Verified business and regulatory requirements were adequately satisfied and verified our systems and processes were compliant with our internal SOP's, external regulatory regulations and audit compliance industry best practices.

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

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

Responsible for documenting and updating business workflow processes and translating them into Business, Functional and User Requirements, User Stories and involved in developing the test strategy/approach for the STP application. The SDLC risk base approach/methodology is being followed to archive production approval.

Working with business owners, underwriters, processors and technical team to help manage projects, write, review and approve Business, Functional and User Requirements, Configuration Spec, develop workflows, process maps, Val Plan, IQ, OQ, & PQ Test Scripts, RTM, Summary Reports, forms, perform Gap Analysis, create workflow and maintenance SOP’s. Involved in Configuration, Implementation and Change Control process in support of the validation effort for the STP application used to process applications for insurance.

Other responsibilities involve performing pre and post reviews and execution of IQ, OQ, PQ/UAT testing of STP application, verifying that the STP application through testing is compliant with state and HIPAA regulatiions and involved in system research and analysis for product and business improvement and future business needs.

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

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

Responsible for documenting and updating business workflow processes and translating them into Business, Functional and User Requirements, created User Stories and Acceptance Criteria's and help develop the test approach for the Pega application.

Worked with business owner and technical team to manage project, coordinate the writing, reviewing and approving of Business, Functional and User Requirements, develop workflows, process maps, User Stories, Acceptance Criteria's, Configuration Spec, Val Plan, IQ, OQ, & PQ Test Scripts, RTM, Summary Reports, forms, Gap Analysis, workflow and maintenance SOP’s, Configuration, Implementation and Change Requests in support of the validation effort for the Pega system a CRM MS Dynamics application used to process applications for medication for patients with or without Health Insurance and for people who can't afford to pay for their medication.

Other responsibilities involve helping manage the validation effort for Pega and performing pre and post reviews and execution of IQ, OQ, PQ /UAT testing and verifying that the Pega application was compliant with 21CFR Part 11 and HIPAA regulatiions.

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

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

Responsible for documenting and updating business workflow processes and translating them into Business, Functional and User Requirements, User Stories and Acceptance Criteria. Developing the test approach, performing System analysis and gathering data and migrating data to be utilized for UAT testing and production.

Working with business owner and technical team to manage project, coordinate the writing, reviewing and approving of Business, Functional and User Requirements, User Stories, Acceptance Criteria's, Configuration Spec, Val Plan, IQ, OQ, & PQ Test Scripts, RTM's, Summary Reports, forms, Gap Analysis, workflow and maintenance SOP’s related to system, Configuration, Implementation and Change Requests in support of the validation effort for inSupport and Salesforce a CRM application used to process applications for medication for patients with or without Health Insurance and for people who can't afford to pay for their medication.

Other responsibilities involved managing the validation effort for PeopleSoft involving (Benefits, Human Resources Management System, Payroll), performing pre and post reviews and execution of IQ, OQ, PQ testing involving inVentiv Health’s workflow SOX and 21CFR Part 11.

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

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

Responsible for documenting and updating business workflow processes and translating them into Business, Functional & User Requirements and UAT Test Scripts. Developed test approach, performed System analysis, managed validation effort, data management and

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