Supply Chain Business Analyst

SUMMARY

Validation Specialist/Lead, Business Analyst, QA Manager, and Compliance Specialist with CSV, Pharmaceutical IT, Product & Device Manufacturing, CAR-T Manufacturing, Cleaning Validation, Software QA experience with extensive experience in QA/Compliance, Testing, SQA, PM, System Software & Instrument Validation, 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. Facility/utilities equipment and lab instruments commissioning and qualification experience.

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 LabWare LIMS 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.

System development, end to end testing/validation and implementation experienced: involving various clinical, manufacturing, ERP, MES, CRM, PLM, CMMS, SAP, Pharmacovigilance systems, Labeling & Packaging Systems Supply Chain systems, SAP S/4HANA, laboratory and facility Equipment, Veeva QMS, RIM, CRM. The remediation of various IT, manufacturing, clinical, labeling and package & CRM systems, such as SalesForce, Microsoft Dynamics 365 involving Cost Management, Fixed Assets, Inventory Management, Product Information Management, Production Control, Warehouse Management, Project Management/Accounting and Supply Chain module. Involved in developing test approaches, System, Functional and User Requirement and Configuration Specifications, Val Plan’s, GxP Assessments, Risk Assessments. Involved in Risk Management, writing Test Protocols Plans, (IQ OQ, PQ,) SIT and UAT test scripts, Summary Reports, Medra and E2B reports, RTM’s, system, test, design, operational maintenance and training SOP's. Serialization and 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). Involved in submissions, amendments, supplements, and reports to FDA's Center for Drug Evaluation and Research. Creating 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 to weed out possible test failures prior to formal execution. Extensive experience with Argus a safety application implementation involving PV operations, configuration, reporting, support and maintenance.

Compliance experienced: ensuring manufacturing complies/adheres to applicable procedures, GxP practices, standards, policies, specifications and SOP's. Involved the reviewing and approving batch records, product labeling and packaging, various manufacturing/shop documentation, authoring, executing, reviewing and approving cleaning validation documentation, Sampling Plans, Acceptance Criteria / Sample size Determinations, QC testing requirements, reviewing and analyzing data, interfacing with Quality to review investigations, interpret results and generate technical conclusions. Involved in the review and approval of deviations, change controls, CAPA investigations, and periodic reviews related to manufacturing of medical products and devices, laboratory instruments, facilities equipment, and various computer applications/systems.

Facility/utilities equipment and lab instrument commissioning and qualification experience: As the QA Compliance Specialist I have provided the quality assurance support and oversight for the commissioning and qualification of facility utility equipment and instruments within manufacturing and various laboratories, supported the upgrades to existing facility utility equipment, and involved in the quality oversight involving automation systems for Amgen's facility. Automation systems include systems such as Delta V, BAS, BMS & SCADA.

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. 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 requirement analysis: using Blueprint and CaliberRM tool.

Experienced in 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 applications SalesForce, Microsoft Dynamics 365, Siebel, ARISg & Argus a Pharmacovigilance Safety, MES, ERP, Watson LIMS, LabWare LIMS, Star LIMS, SAP Solution Manager and various other modules such as (QM), (MM) & (PLM), S2P process, SAP SCM. 8.8. 6.7 Drug Supply TrackWise, Chain Systems SAP HANA, Labeling & Packaging Systems, Maximo, Master Data, Quality Management System (QMS), PeopleSoft, CAR-T Manufacturing.

Merck – Watson LIMS v7.6.1, Spectrum 4.0 an Oracle based Siebel Clinical Trail Management System, TrackWise, istudyReporter, SAP Manufacturing and modules (QM), (PLM), (MM), (PM) (MD), S2P process, SAP S/4HANA, 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, Microsoft Dynamics 365, Siebel, Managed Markets, 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), 21CRFR1271, ISA S88 & 95, IEC 62304, ISA95 standard, GAMP5, GMP, cGMP, GCP, GLP, QSR 21, MDD. ISO 9000, ISO 9001, ISO 13485, ISO 19227, ISO 14971 & ISO 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, Medical Device Marking and Labeling standard, IEC 62443, 62443-4-1, 62443-4-2, 624**-*-*-***** and IEC 60601-1 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, 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, Watson LIMS, ELN, LabWare LIMS, 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 365, 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 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 their LIMS application to perform Clinical Trials on various live stock .

Amgen Thousand Oaks CA 10-20 to 11-23

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

Support and manage the Validation, Remediation, Administration and Qualification of various computerized systems such as LIMS, ALM 15.5, Pharmacovigilance Systems, Veeva Vault, RIM, Watson LIMS, CRM, LabWare LIMS, Master Data, PeopleSoft, SalesForce, Microsoft Dynamics 365, Siebel, SAP (QM), (PLM), (MM), (PM) (MD), models, S2P process, SAP HANA, Quality Management System (QMS), PeopleSoft, Star LIMS, 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, Sample size Determinations, QC testing requirements, reviewing and analyzing data, investigations, interpreting 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 the creation, review and approval of deviations, change controls, CAPA investigations, and periodic reviews from past validations, manufacturing of medical products and devices, laboratory instruments, facilities equipment, and various computer applications/systems. 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). Involved in validating Microsoft Dynamics 365, ensuring computerized systems are in compliance and operating efficiently within a facility contributing to a successful implementation.

As the QA Compliance Specialist I provide the quality assurance support and oversight for the commissioning and qualification of facility utilities equipment and lab instruments within manufacturing and various laboratories, support upgrades to our existing facility, and involved in the quality oversight involving automation systems for Amgen's facility. Automation systems include systems such as Delta V, BAS, BMS & SCADA.

As the Validation Specialist/Lead I am involved in performing dry run testing, writing, reviewing and approving Requirement and Configuration Specifications, Validation Plans, Risk Assessments, Test Protocol Plans, test scripts, IO, OQ PQ and UAT Test Protocol Plans, Traceability Matrices, SOP's, Summary Reports, Technical Recovery Plans, System Retirement Plans. Involved in Risk Management 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 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

Validation Specialist / Business Analyst / QA 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, Risk Management, Validation, Remediation, Administration, and Qualification of various computerized systems and lab instrument stations consisting of various types of analytical and bio-analytical instruments in a GxP and non-GxP 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 authoring, executing, reviewing and approving cleaning validation documentation, Sampling Plans, Acceptance Criteria / Sample size Determinations, QC testing requirements, reviewing and analyzing data. Involved in the review and approval of deviations, change controls, CAPA investigations, and periodic reviews related to manufacturing of medical products and devices, laboratory instruments, facilities equipment, and various computer applications/systems.

I provide the quality assurance support and oversight for the commissioning and qualification of facility utilities equipment and instruments within manufacturing and various laboratories, support upgrades to our existing facility, and involved in the quality oversight involving automation systems for Merck's facility. Automation systems include systems such as Delta V, BAS, BMS & SCADA.

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), S2P process, SAP S/4HANA, 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

Validation Expert / Quality Assurance (Consultant)

Supporting and managing the Quality Assurance, Administration 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, Risk Assessments, Risk Management, 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. Involved in the review and approval of deviations, change controls, CAPA investigations, and periodic reviews related to manufacturing of medical products and devices, laboratory instruments, facilities equipment, and various computer applications/systems.

SANOFI, Bridgewater NJ 5-17 to 6-18

Validation Expert / Quality Assurance / Business Analyst (Consultant)

Supported and managed the Quality Assurance, Validation, Remediation, and Administration 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, validation of Veeva Vault eQMS, RIM, CRM Watson LIMS LabWare LIMS. Involved in 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, Risk Assessments, Risk Management, 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. Involved in the review and approval of deviations, change controls, CAPA investigations, and periodic reviews related to manufacturing of medical products, laboratory instruments, facilities equipment, and various computer applications/systems.

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, 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 / 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 / QA Compliance Specialist (Consultant)

IMCLONE SYSTEMS, Branchburg, New Jersey 3-12

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