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Experienced Computer System Validation Principal Consultant, with M.S. Computer Science and M.A. in Education, PDA Auditor Certification, and more than 20 years working with computer systems used in the Life Science industry.Areas of Expertise - Computer Systems Validation, Auditing, Quality Assurance, Technical Writing, TrainingStrengths: Strong organizational and technical skills. Highly detail-oriented and quality-focused with exceptional written and verbal communication skills. Abilities to lead/delegate, work independently, work remotely, as part of a team to accomplish objectives. Ability to work on multiple local and international projects simultaneously with people from varied backgrounds and skill sets. Dependable individual with integrity and commitment to excellence.Professional ExperienceSpectraforce, June 2022-March 2023Non-Product Software (NPSW) Quality Engineer)Validation of Abbott Diagnostics (ARDx) NPSW project (DIGIVAL Production Tester package, as per Software Development Life Cycle); Spreadsheet validation. Participated as team member, and authored validation documentation including User Requirements Specifications, Functional Requirements Specifications, and other deliverables. Spreadsheet review and related validation activities. 100% Remote. (Abbott)Oxford Life Sciences, 2017-2020, ConsultantIT Services and Solutions Delivery - IT Vendor Risk Management, part of Cyber Security Risk ManagementReview various Company Business intended use of requested vendors; identify inherent risk areas (e.g., Quality, Electronic Records/Signatures, Software/System Development Life Cycle, Privacy) based upon intended use; work with Business areas and vendors to review vendor controls; review and write Executive Summaries of assessments; work with vendors to document/remediate findings; review progress of new assessments and periodic reviews of vendors; identify areas for improving risk for Business areas, providing consultation to Business on risk, the assessment process and goals. 100% Remote. (Abbott)M. S. Goldman & Associates, Ltd., 2015-2016, Principal ConsultantComputer Systems Validation, Auditing, Quality Assurance, Technical Writing, TrainingSAP validation documentation including Functional Specifications and PLDM (Product Lifecycle Data Management) Test script development for Document Information Records Management and Physical Building Blocks/Physical Structure of data. 100% Remote. (Philips)IGATE Corporation, 2005-2014, Principal ConsultantComputer Systems Validation ManagerAs Validation Manager, led validation team on several global projects for a medical device client. Authored validation documentation including validation plan, test plans, test summary reports, validation summary reports; review and approval of testing; providing guidance for user requirements specifications and data migration; provided coaching to client engineering staff and other validation consultants. Projects included Engineering Tool systems, MFGPRO, Oracle projects for Global Supply Chain - UDI (Unique Device Identifier), eDHR (electronic Device History Record) and Oracle Pedigree and Serialization Manager. Extensive use of HP Quality Center tool. Primarily 100% remote. (GE Healthcare)Validation Manager at a medical device client for mobile applications used in surgical settings, and an electronic copy/approval system for marketing materials (labeling). Approximately 50% remote. (Johnson& Johnson)Computer Systems Validation Quality AssuranceProvided quality and compliance support for a vendor producing Infrastructure management SaaS software system, developed using Agile, for use by a major Pharmaceutical company. Authored Quality Management System, Quality Manual, SOPs including Management Review and CAPA. Validation Manager for current system. Provided training materials on Computer System Validation, GxP Regulations, and 21 CFR Part 11. Approximately 50% remote. (ServiceNow for Johnson & Johnson)Provided quality, compliance and audit support and coaching for a software development company with sales to pharmaceutical industry of a product used to data-mine Adverse Events database. Authored Quality Management System, SOPs, SDLC, and Validation documentation. Provided training on Computer System Validation, GxP Regulations, and 21 CFR Part 11. Approximately 75% remote. (DrugLogic)Computer Validation subject matter expert/QA facilitator for validation of automated Manufacturing systems. including Process Center Control Systems, Liquid Bulk Receiving, Reverse Osmosis Water System, Batch Reporting, PLC Change Management, creating SDLC, Document Control/Management SOPs for the client organization, performing Risk and 21 CFR Part 11 scope assessments for systems being validated, auditing of software vendor for Calibration software. (Mead Johnson)Computer Systems AuditingLead auditor for many onsite and remote supplier assessments/audits for medical device and pharmaceutical clients, conducted assessments, authored reports, and provided feedback to client and vendor. Internal, vendor and contractor computer systems audits. Audited compliance to corporate standards and GMP/GCP/21 CFR Part 11 regulations and guidances including CFR 210, 211, 820, 21 CFR Part 11, CFR 50, 56, Annex 11, various local country standards, GAMP, and some SOX security requirements. Audits included EDC (Electronic Data Capture), IVRS (Integrated Voice Response), Calibration, and Global Manufacturing ERP systems as well as IT programming and development resource vendors and data centers. (GE Healthcare, Takeda, Various)Quality Coaching/TrainingProvided Quality Coaching and authoring expertise to clients for several large-scale GMP/GCP validation projects; Quality Coaching to individuals as part of a Validation Manager/Qualification certification program. Projects included validation of several GxP ERP systems used for service, order-to-remittance, and finance for Supply Chain for manufacture of regulated medical devices and to maintain Service Call records for Asia and Italy. (GE Healthcare)As Client-Certified trainer, provided on-site and Webex training to staff on Corporate QA Computer System Validation procedures and work instructions, CSV basics, User Requirements and Testing, and Validation Planning and Change Management. (GE Healthcare, IGate/Patni/Taratec)Authored and presented white paper internally on e-pedigree systems for compliance with Federal laws governing the electronic tracking and tracing of the manufacture, sale, purchase, distribution, or trade of a drug. (IGate)Technical DocumentationAuthor/review/approval of compliant Validation documentation including performance/review and documentation of risk assessments, GxP assessments, supplier assessment. Review/approval of user requirements, system and design specifications, testing, and test results and Requirements Traceability Matrices. Extensive knowledge and use of HP Quality Center. (GE Healthcare, Mead Johnson, Gilead)Prepared inventory of software and computerized systems currently in use as part of a major corporate client initiative to complete validation of software and computerized systems used to meet regulatory requirements. (Boston Scientific)Searle/ Monsanto, Pharmacia, Pfizer, Inc., 1996-2005, Consultant (1996-1999)/Employee (1999-2005)Computer Validation Quality Assurance Manager, Pfizer Legal Division, Regulatory Compliance Senior Auditor, Computer Validation Quality AssuranceProvided Quality Assurance consultation, review and approval of all validated computer systems (GMP, GLP, GCP) used to support R&D and R&D/ Global Manufacturing projects to assure compliance with regulatory and corporate procedures. Provided oversight internal auditing (domestic and international) of GMP, GCP, and GLP computer systems used to support the development, clinical trial, manufacture (API and drug production), and distribution of pharmaceutical products for human and animal use. Audited validation documentation and usage of computer systems as well as data centers against corporate standards, policies, requirements and regulatory and industry rules, standards, and guidances.M.S. Goldman & Associates, Ltd. 1991-1999, ConsultantTechnical Documentation and TrainingDeveloped validation documentation, plans, requirements, specifications, test protocols, reports, for R&D projects including SQL*Protocol (part of SQL*LIMS); GRANITE, an animal resource management system. (Searle)Developed validation documentation, plans, specifications, test protocols, user and administrator manuals, for PPD (Pharmaceutical Products) division projects: Data Management Quality Assurance (DMQA) System used for QA of clinical trial data, and CDME (Clinical Data Management Environment). (Abbott)Developed and reviewed project validation documentation (including requirements, specifications, test protocols) for health information network transactional processor connecting hospitals, doctors offices, and insurance providers. Project was a joint venture between Ameritech and Aurora Healthcare Corporation of Wisconsin. Compliance to HIPAA and processing requirements. Developed training curriculum for Ameritech region. (Health Network Ventures)Developed technical documentation, user and administrator documentation for a network management system used to monitor and report Customer switch and trunk information. Conducted, facilitated design review. Provided training to technical and non-technical users. (Ameritech)Pyramid Technology, 1989-1991, Senior Systems EngineerTechnical support for sales to Financial/Commercial-Healthcare Market clients.AT&T Bell Laboratories, 1979-1989, Member of Technical StaffSite Lead R&D UNIX Systems Administrator and Software Engineer; Divisional Quality Program Group and Customer Technical Support; Feature Test Engineer in 5ESS International Switching Laboratory, Feature Test and Quality Group.