SUMMARY:

• Dedicated professional who gives 110% to every project and will effectively validate a software system/application/medical device.
• Extensive background in Computer System Validation (CSV), Software Quality Assurance (SQA) and Testing having generated various quality and validation deliverables.
• Strong technical and analytical abilities with excellent interpersonal skills and exceptional documentation skills.
• Self - starter who is organized, efficient and meets deadlines without sacrificing quality.
• Proven history of collaborating with team members, business owners, project managers and ensuring products meet business, functional and compliance requirements.
• Multi-tasker who enjoys working in a fast paced environment.
• Naturally detail oriented and adaptable.
• Experience managing entire life cycle from a validation perspective and as well as overseeing testing efforts on numerous occasions.

TECHNICAL SKILLS:

Automation & Test Management Tools: ALM Complete (SmartBear), HP Quality Center (QC), QuickTest Professional (QTP), LoadRunner

Software and Business Applications: SharePoint, DocSpace, Documentum, Office 365, TruVault, LIMS Labware, SAP, Shop Floor D Confidential, MS Office (Word/Excel/Outlook/Visio), MS Visual SourceSafe, eRoom, MS Lync (conferencing and instant messaging)

OS: Windows 7/Vista/XP/2000/98

Languages: HTML, XHTML, XML, CSS, JavaScript, SQL

LMS: ComplianceWire, Summit

PROFESSIONAL EXPERIENCE

Confidential, Flemington, NJ

SENIOR CONSULTANT

Responsibilities:

• 18+ years experience providing validation and compliance services to the life sciences industry
• Authored validation deliverables such as Validation Plans, Test Plans, and Summary Reports
• Implemented risk-based testing approach to validate critical features on priority basis
• Change Controls - track/report/manage process of system changes, ensuring conformity to rules
• Strong manual and Black Box testing of web based application (functional, integration, system, regression, navigation)
• Successful testing and documentation of major and minor upgrades in parallel with multiple corrective upgrades and numerous custom client work orders annually
• Experienced coordinating, leading and participating in testing efforts, managing onshore and offshore test teams and non-QA personnel
• Proficient in designing, preparing, modifying, enhancing and executing manual test cases and scenarios
• Good understanding of QA methodology, Software Development Life Cycle ( SDLC ), Software Testing Life Cycle ( STLC )
• Knowledge of automated testing tools ( QTP, LoadRunner )
• Experience with test management software ( HP QC and HP ALM Complete )
• Experience in Defect Reporting, Tracking, Management

Confidential, Madison, NJ

QUALITY ASSURANCE SPECIALIST - Consultant

Responsibilities:

• Provide independent quality review for key validation deliverables and activities.
• Provide assurance of all applicable health authority regulatory (HAR) requirements pertaining to cGMP, cGLP, cGCP and cGDP, electronic records, electronic signatures for both pharmaceutical products and medical devices.
• Ensure Confidential policies and procedures are followed throughout the software development life cycle for multiple GxP systems.
• Provide final approval prior to release of the system and provide final closure approvals of change requests in ServiceNow.
• Perform CSV periodic reviews to ensure global computer systems remain compliant with regulations and continue to satisfy Confidential policies and procedures.

Confidential, Spring House, PA

COMPLIANCE AND VALIDATION SPECIALIST - Consultant

Responsibilities:

• Provide a wide range of computer system validation services in support of new implementations and changes to existing systems
• Ensure regulatory compliance, compliance with corporate policies/procedures, and industry best practice standards. Knowledgeable of CGMPs, GLP, CFR Part 11, GAMP 5.
• Manage all aspects of the SDLC as it pertains to validation
• Gather/develop/review/approve all validation deliverables including CA, change control plans/reports/summary (CCP/CCR/CCS), user requirements specifications (URS), Security, Configuration, business requirements (BR), functional requirements (FRS), technical/system design requirements (TDS), requirements traceability matrix (RTM), RTM, reports)
• Manage all testing efforts from preparation of test cases & protocols to execution, review and approval for System, UAT, IQ/OQ/PQ
• Provide and guidance on Good Documentation Practices (GDocP)
• Aid the client with understanding the validation process, its benefits, the necessity
• Manage tasks based on aggressive timelines
• Provide assistance with internal audits and drafting CAPAs
• Draft SOPs, WIs, release notices

Confidential, Swiftwater, PA

SOFTWARE QUALITY ASSURANCE ANALYST - Consultant

Responsibilities:

• Develop test strategy based on risk analysis of requirements
• Design and develop test cases from written requirements, functional specs and storyboards
• Analyze requirements, tests, and test d Confidential to identify gaps in requirements coverage
• Develop test d Confidential scenarios for testing parameter values coming from LIMS, SAP, and SFD systems
• Perform System testing and execute dry runs of UAT test cases

Confidential, Whitehouse Station, NJ

QA TEST LEAD (UAT) - Consultant

Responsibilities:

• responsible for planning, guiding and executing the steps necessary to promote product quality according to Merck's QA and Compliance standards work in an Agile Scrum environment with software engineers, product management, tech leads, and client provide guidance to the client UAT team on test planning and test case creation review UAT test cases to ensure compliance with external regulatory agencies and client's procedures and facilitate testing efforts act as product SME to both UAT and in-house QA teams
• Review quality/validation deliverables and create the Confidential QA test plan
• Work with client to produce end to end workflow/process diagrams
• Analyze business requirements and existing functional requirements to prepare a gap analysis report
• Gather functional requirements, writing new and modifying existing for both web and mobile applications
• Create entire Requirements Traceability Matrix (RTM)
• Work with internal QA Team performing regression testing, defect validation, build verification testing as well as providing guidance and leadership

Confidential, New Providence, NJ

VALIDATION ANALYST - Consultant

Responsibilities:

• Electronic information management system validation
• Review documentation including test plan, URS, functional specification for completion
• Develop test cases based upon user requirements and system specification docs with an emphasis on functionality related to security, audit trail, and electronic signatures
• Design complex UAT test cases and scenarios to include both high and low level test steps
• Ensure test cases provide coverage of system compliance with regulations 21 CFR Part 11, 21 CFR Part 1271, and CMS 42 CFR Part 413, 441 (as applicable)
• Participate in UAT testing activities including review, investigation, and resolution of issues identified

Confidential, Middlesex, NJ

VALIDATION - Consultant

Responsibilities:

• Map Process Definition Documents (PDD) to SAP Configuration Documents to uncover non-implemented requirements
• Review and edit SOPs
• Generate Process Flow Diagrams based on SOPs and PDD
• Generate Security Matrix based on department and role

Confidential, Princeton, NJ

SOFTWARE QA ANALYST - Lead

Responsibilities:

• Validation of ComplianceWire® Web-Based LMS used by regulated companies and government agencies
• Validation of Change Management and Defect Management applications developed in house
• Performed various Administrator duties for ComplianceWire (creating accounts, assigning and managing curricula)
• Change Control Administration - track/report on open changes, ensure user conformity to the rules
• Manage all reported defects from a QA perspective. Track and ensure correction, retest and in corporation into product builds and validate in production environment.
• Ensure compliance of ComplianceWire with 21 CFR Part 11 requirements and Section 508
• Established various SOPs for QA testing, defect reporting and tracking
• Design, implement and execute test cases for new and modified system requirements ensuring complete coverage of new code. Responsible for creating >80% of a 6000+ test suite.
• Work with Developers to resolve defects with new functionality and assist in design of future functionality and enhancements
• Work closely with Project Managers and Developers testing custom client work orders including feeds, http posts, d Confidential uploads, and client requested system enhancements
• Work directly with clients (e.g. Stryker, Cephalon, JNJ, Abbott Labs) supporting custom work and UAT activities. Included development of test cases and scenarios, leading and participating in execution, defect management
• Provide 2nd level customer support assisting Client Services in verifying and troubleshooting issues identified by clients
• Prepare and review functional and user requirements for feature functionality
• Prepare and maintain various validation and Quality Management System QMS documents
• Participate in client audits supporting all aspects of SQA activities
• Execute manual testing of both Client Server & e-learning courses on multi-configuration setups for functionality and performance, ensuring quality and accuracy
• Ensure all software conforms to business and technical requirements
• Developed and maintained traceability matrices