ERP / Enterprise System Validations & Project Management (Class 1 and 2 medical devices):• Author validation master plan (VMP), risk assessments RA/FMEA, validation plan/protocols (VP), user requirements specifications (URS), functional requirement specs (FRS/SRS), design specs (DS), UAT's with test cases, traceability matrix (TM), testing (SAT, IQ, OQ/PQ), and Validation Summary Report (VSR). • Developing all (above) SDLC deliverables for retrospective SAP Business One Professional (SBO) and prospective SaaS (web based) Master Control and SBO validations.• Author Work Instructions / SOP's and Admin SOP's for SBO and Backup & Archive systems/process.• Coordinate with other departments to complete validation tasks. • Support resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements. • Investigate/troubleshoot validation, quality, and computerized system issues, provide solutions and create mitigation/improvements plans. • Participate in regulatory audits. • Conduct validation training. • Manage projects and prepare status reports as applicable using Smartsheet and other tools. • Provide compliance support, guidance and expertise.• Supporting ad-hoc qualification/validation of equipment (e.g. Keyence CMM Comparator), test and manufacturing fixtures, Shipping and Manufacturing Process Validations.• Support Kaizen events and DMAIC activities.• Creating curriculum and training departments in the use of various software tools including SmartSheet and SAP.=> Projects: Master Control v2018.3 Quality Module and SAP Business One Prof validations; Barcoding and Brexit/Global Relabeling & Rebranding Qualifications.

Providing validation support to various VPI clients.

• Authoring & Executing CSV SDLC docs (Req's, VP, VMP, IOQ, PQ, V&V, TM, VSR) Facility, Utility, Lab Systems, IT infrastructure, Equipment, Process, Test Method, and Cleaning Validation Protocols / IQ, OQ (UAT), PQ for stand-alone and complex systems/software including PLC’s, MES, SCADA, SDS, CDS, SDMS, PLM, LIMS and ERP.• Performing audits, gap assessments, reports, and resulting remediation plans, resulting from observations during internal/external audits and clients under a consent decree or experiencing 483’s observations. • Engaging in QA/QE and Business Analysis, including CAPA’s, OOT/OOS/IR/DR investigations, change control / risk management and FMEA, data analysis, SAT/FAT, metrics.• Developing SOP’s, Policies, User, PM, Cal, QA, Admin procedures.• In the area of Med Devices & IVD's industry, also, providing DHF, DHR, DS, V&V, device dev support, developing u/d/pFMEA's. • Managing/supervising team of QE’s and Project Managing complex remediation, implementation, product transfer (including scale-up) and development activities.• Implemented EH&S practices. Auditing for EPA and OSHA compliance.• Working with local (startup, scale-up, transfer) as well as global clients (in acquisition phase and those with an established Global presence). List of clients served in the new millennium:* Illumina* Advanced Bionics* Calhoun Vision* Gilead Sciences* Bard | Neomend | Davol* Irvine Pharmaceutical Services (Nitto Avecia)* Covidien (Medtronic)* Siemens Healthcare* Abbott Medical Optics* Teva Parenteral Medicines* Boston Sci Neuromodulation* WaveTec Vision (acquired by Alcon)* LensX (acquired by Alcon)* Amgen* Applied Medical* Edwards LifeScience* Intralase (acquired by Abbott)* Dendreon * STAAR Surgical* Baxter BioSciencePlease note that below is only a partial list of clients.

1st Phase: TMV's----------------------------------------------------------------------------------------------------------o Authoring, executing, reviewing, and approving: Gage-R&R, TMV’s (Cat 1-4: ID, Quantitative, Limit, Content/Potentcy, Function/Performance: accuracy, precision, repeatability, specificity, detection/quantitation limit, linearity, and range).o Authoring, executing, reviewing, and approving: IOPQ’s (EQ’s) on production QC systems / instruments (e.g. Agilent HPLC, Atago Digital RI, RheoSence Viscometer, PHOENIX optical measurement and testing system, Nikon VMZ-R / VMA defect inspection and dimensioning systems, Typhoon Scanner Functional Fluorescence, Zygo Interferometer, Ellipsometry system)o Co-developed DOE’s (full/fraction factorial, Plackett Burman, Taguchi screening, CC, Box-Behnken), feasibility / engineering / system suitability studies. o Training/consulting with team to achieve most efficient statistical assessments.2nd Phase: CSV's----------------------------------------------------------------------------------------------------------o Performing risk assessments / FMEA on software & computerized systems. o Authoring, executing, reviewing, and approving SDLC documents including URS, SRS, FRS, SDD, VMP, VP, V&V, IOQ’s test scripts, integration testing, UAT, VSR on Oligonucleotide sequencing and amplification manufacturing system (e.g. Sequencer, Camstar MES, Oracle-Java LIMS, DesignStudio, Venus/Hamilton aliquoting systems, SpectraMax microplate reader with Mars software, and Perkin Elmer Mass spectrometer).

Diagnostic Laboratory (21 CFR Part 58 GLPs).• GLP Lab preparation activities. • ERES assessment and validation activities• Validation of Lab Equipment (e.g. Beckman centrifuge, BioTek microplate reader, Gen5, etc).

Class 3 Medical Devices.* Generated Site and Facility/Utility Master Validation Plan.* Assisted in development / implementation activities for mechanical, IT Network infrastructure, electrical, plumbing, ESD / Cleanroom (class 7 & 8), process gases, compressed air, architectural, IT Infrastructure, and Backup Generator, design specifications per facility layouts/plans. * Authored and where necessary executed Facility/Utility Validation Plan. * Resolved inconsistencies between design specifications, client requirements, and drafter's layout.* Provided instructions for remediation and as-is verification.* Generated facility, utility and equipment validation documentation* Supported EH&S, Cal / Fed OSHA, and OCFA activities.

• With respect to Lab Systems, responsibilities consist of SDLC activities per GAMP5, 21 CFR Part 11 and Annex 11:o Assessed for regulatory and corporate compliance of: Master Validation Plan(s), Requirement Specifications, Validation Protocols, IQ, OQ, PQ Test Script, Trace Matrix, and Validation Summary Reports, pertaining to Empower 3.o Provided technical/regulatory comparison of Empower 3.5 vs. Chromeleon 7.2 to management.o Performed software Risk Assessments.o Supported change control activities.o Assessed for compliance and policy/regulatory alignment of computerized system relevant SOP’s, including Administration, Use, Backup / Archiving, Decommissioning, and Periodic Review. o Consulted with stakeholders such as business owners, technical owners, and subject matter experts in the deliverables development, review, and approval process to maintain compliance/adherence to regulations and industry standards.o Supported the development of User Acceptance Testing.

Class 3 Medical Devices.• Directed a team of quality engineers in product integration project. • Generated Quality and Process / Equipment / Design Validation procedures / procedures / policies.• Generated dFMEcA and pFMEcA for stent product of an acquired stent manufacturer, “Reverse Medical”.• Performed gap analysis of current manufacturing and design/process against DS, clinical data, and DHF documentation. This included generation of remediation plan for quality relevant documentation, dimensional and functional testing.• Improved and created inspection points / test methods.• Reviewed / commented on QP and MP SOP’s and trained QEs and MEs on proper drafting of documents.• Generated Gage R&R and Test Method Validations.• Trained engineers and generated various tool / test fixture Feasibility, Engineering, and DOE studies.• Improved and implemented compliance to an existing process.• Migrated and implemented a fully manual process into semi-automated operation.• Developed a training program for operators, inspectors, and QC leads / supervisors.

• Generated compliance gap asmt on process & data analysts (by shadowing/investigations), CatsWeb SQL dBase and SAP per FDA, EMEA, HCan, CFDA, CDSCO, MHLW, TGA, MHRA, AMO global, & divisional policies & regulations with respect to product safety & compliance metrics (i.e. Post Market Surveillance, Adverse Events, MDR, monthly, quarterly, & annual regulatory agency submission).• Created 21 CFR Part 820 / ISO 13485 (GxP), 21 CFR Part 11 / Annex 11 (ERES) compliance gap remediation plans and risk assessment, which included implementation & integration with existing technology (i.e. SAP Business Intelligence / Business Objects and Query Web Client).• Revised existing process & validation SOP’s to comply with GxP, ERES, global, divisional policy.• Generated technical Work Instructions (WI) for Adverse Event (AE), MDR, quarterly & annual product safety / complaints trending & data acquisition process between CatsWeb and SAP.• Performed gap analysis, generated a remediation report, & Validation Protocols for PMS (post market surveillance), AE, MDR, and Complaints Tracking spreadsheets.• Generated VMP, Risk Assessment, URS, DS, FS, IOQ (including test cases), Trace Matrix, and Summary Report for complaints trending & process capability study spreadsheets.• Tracked and reported on progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, & assisting teams with contingency plans.• Managed activities to resolve project issues with team members & project stakeholders: subject matter experts (SME’s), Business Owners (BO’s), and Technical Owners (TO’s).• Authored / executed validation & verification documentation, GAMP5 SDLC documentation & reported on activities / deliverables pertaining to product trending systems/processes.• Trained team on strategies for improved trending accuracy between CATSWeb & SAP.

• Authored Requirement Specifications (i.e. URS, FS, SDS) and functional Test Scripts for Waters ELN Forms used at Teva North America / Teva Pharmaceuticals.• Authored requirements and test scripts in Quality Center v10.• Authored SDLC documentation such as Validation Master Plan (VMP).• Resolved deviations in Quality Center and TKS.• Trained technical owner on GxP / 21 CFR Part 11 (ERES) requirements and testing scripts.

• Maintained and assured compliance of current/new Computerized & Automated Systems:o Assured the compliance of requirements with respect to system, user, procedural, interface, data, business, and regulatory requirements.o Provided support for the creation, review and approval of deliverables such as VMP, URS, FDS, DS, SDS, IQ / OQ (including UAT, Integration, functional) / PQ, Vendor Audits, TM, VSR, RA, and Administration/ /Use/ Maintenance & Periodic Review SOP’s.o Ensured the completion and approval of SDLC docs and deliverables, the validation status, approval for system release.o Organized/maintained meetings and provided Quality Unit SME guidance with respect to site, global, and regulations (ERES / Annex 11).o Identified issues and resolved at root cause with respect to criticality, risk/severity and regulatory/business requirements.o Tracked/documented activities issues, severity, risk/severity, and provided progress/issues/remediation plan reports to upper management.o Trained users and stakeholders, including Business/Technical Owners on GAMP SDLC process, procedural and policy.o Developed, revised, edited, and implemented validation policies and SOP’s pertaining to Lab System Assays/Methods, Change Control, System Administration, Maintenance, and Calibration per local and global SOP/Policies, current regulations and industry standards.• Additional responsibilities consist of:o Supported CAPA process as it relates to Deviations, Complaints, Investigations, Observations and OOS.o Reviewed, revised, and approved Admin, Use, Method, Assay, Instrument, and Computerized SDLC SOP’s.o Supported Audits as a Computerized System QA SME.o Reviewed/commentated and where appropriate approved Change Requests in TrackWise and Critical & Non-critical System Change Requests.o Trained stakeholders with respect to ERES, relevant procedures (e.g. change control, spreadsheet validation requirements, authoring of SDLC documentation, etc).

• Authored and executed Validation Documents (SDLC documents: VMP, FDS, URS, SCS, IQ, OQ, PQ, TM, VSR, Admin SOP, Change Management documents) for Laboratory Systems / Instruments and Engineering Controls.• Performed periodic review of software / system, Part 11/ ERES assessments and prepared formal reports.• Revised and assisted in revision/creation of SOPs with respect to Use, Administration, and Maintenance. Some of the Systems Remediated to-date: Leica Mic, IC Chromeleon Dionex, AA ThermoScientific, Turbisoft/Turbiscan, GC/MS and LC Chemstore/Chemstation/Kiosk, Honeywell Chart Recorders (MiniTrend controllers) with TrendManager SCADA System, Agilent Chemstation UV-Vis, Symantec GhostCast Imaging. Technical reviews and audits performed on: LIMS, LS, ELN, Empower, FirstDoc, Chemstation, AA, GC, LC, DSC/TGA, Turbidity, Particle sizers, BM-CalMan, TOC, Instron, Vitek, NuGenesis, etc.

For LensX:• Provided Chemical assessment and compliance activities per CERCLA Emergency Planning and Community Right to Know Act, Hazardous Materials Transport Act, Toxic Substances Control Act and OSHA health Act. • Interacted and coordinated compliance activities including completing forms for agencies: OCFA, EPA, OSHA, DOT and corporate insurance agents. • Prepared appropriate documentation, required forms, informed agencies on status and coordinated inspections. • Authored and executed facility, utility, and equipment validation protocols and provided guidance on safety and regulatory needs per ISO 13485, QSR, GMP, EPA, OSHA, OCFA, and FDA regulations.

• Created Quality Department’s Project Plan and Resource Predictor Model for product life cycle: pre-clinical, Phase 1/ 2/ 3, regulatory filing, commercial and contract manufacturing. • Defined structure and business needs. • Provided suggestions on quality resources and budget requirements. • Organized meetings and review with executives/stakeholders, gaps / inconsistencies within resourcing and budgeting.

• Developed all GAMP required SDLC documentation for validation of SAP modules in CA, Europe, and Australia. • Development of blueprints, landscape design, technical architecture, system requirements specifications, functional design specifications, risk analysis, traceability matrix, unit/integration test scripts and other supporting documentation. • Trained team on GMP/GDP/ISO/QSR/EMEA regulatory needs and validation process. • Validated the WM-RF Barcoding, FICO, MM, PP, SD, CO, and FI modules.• Consulted and audited WLAN, RF site survey and stress testing scripts, execution and reports. • Developed, maintained, and tracked validation deliverables

Many of Edward's components, raw material, and textile assembly/manufacturing vendor sites were ending contracts with Edwards, ceased to produce the materials needed, or were needed for new devices. Provided support in qualifying new material and vendors.• Reviewed / commented / approved: FMEA’s, specifications, drawings, protocols and data which would be later submitted to the agency, corporate, site executives/management.• Generated reports and remediation action items based on gaps / deviations.• Performed statistical analysis on data gathered by field CQA's and Quality team members.• Reviewed for compliance and adherance to FDA regulations / standards and device requirement specifications: o Statistical analyses protocols o Test Methods used and TMV's o Validation plans o Sampling plans o SPC results o DOE results• Provided guidance / training based on statistical analysis, FMEA, sampling plan, and compliance against ASTM/ANSI regulations / standards.• Convened in daily update meetings providing project status, milestones accomplishments, deliverables, and present bottlenecks with proposed resolution.• Advised management / team on contingency and backup plans to keep in compliance with challenging vendors, suppliers, manufacturers.

ERES VALIDATION SPECIALIST CONSULTANT (Aug 2006 - Dec 2006)• Executed QNX embedded software GUI test scripts on the FS Laser system.•Documented deviation observations, resolved / mitigated, and re-executed.----------------------------------------------------------------------------------------------------------QUALITY ENGINEER / VALIDATION SPECIALIST CONSULTANT (Nov 2000 - Dec/2003 & Jan/2005 - Jun/2005)• Authored / executed assembly equipment (e.g. IOQ/PQ on cone adhesive system), facility / utility, and process validations.• Executed equipment, test methods and ERES compliance audit.• Prepared safety, chemical storage, and industrial hygiene assessments / reports.

• Developed statistical method / plan, performed statistical analysis, DOE, sample size and number of runs determination, and established efficacy acceptance criteria for Provenge immunotherapeutics Process Validation and manufacturing capability. • Evaluated statistical data to make determination regarding molecular, cellular, and protein efficacy & potency data for IND and NDA submission to the FDA.• Developed cleaning validation method for Commercial Immunotherapy Manufacturing Facilities. • Developed Risk Analysis and pFMEA for systems, documentation and manufacturing processes. • Supported Biostatistics department with respect to clinical studies in SAS. • Provided general statistical training to Quality Assurance members.

Assisted in strategies / methods for technology transfer from Switzerland and France to production in Eastern Europe with respect to 91/412/EEC.

• Validated Blue Mountain Calibration System 4.0. • Created master validation for in-house databases and DataStream MP2. • Created proposals and coordinated validations activities with IT (Computer) department. • Negotiated discounts with software vendor.

• Assessed ERES compliance over many US and International facilities. • Maintained an inventory of over 2000 manufacturing GxP system including validation compliance, ERES compliance, SDLC remediation responsibilities, calibration, remediation tasks, budget, and SDLC documentation status. • Provided reports/status updates to management on a need to know basis.• Researched best ERES solutions / technologies for Part 11 compliance, global implementation, user friendliness, and budget. • Performed Global ERES budget analysis & applicability. • Developed & Maintained Development Life Cycle (SDLC) Validation documentation for global manufacturing computerized systems and software. • Provided support for implementation & completion of Corporate Charter.

• Provided professional guidance on 21CFR Part 11 requirements and software validation needs for CatsWeb. • Audited existing procedures and developed CatsWeb software validation.

• Validated lab and manufacturing equipment, test methods, facility, and manufacturing processes. • Oversaw V&V and design transfer. • Provided technical training to technicians and lab personnel (e.g. GxP’s, ISO, QC techniques, sampling, etc) • Provided assistance in the lab, production and warehouse . • Created supplier and vendor audit procedures, process, and performed/executed as needed.• Maintained Material Review Board, Quarantine and Approval process. • Was responsible for qualifying and purchasing lab instruments, reagents, and chemicals.• Created procedures for and performed receiving and QC inspections on incoming/raw material.• Enhanced, designed and maintained control of material via Material Resource Planning (MRP) system database. • Performed assessment of Industrial hygiene, safety and GLP, generated reports, generated remediation action plan and remediated observations per plan. • Created / executed metrology and maintenance procedures. • Assessed QSR's and ISO9000 compliance in all phases of product development, generated reports and remediation plans.• Provided IT technical support to all company employees and system development/improvement.

• Validated / re-qualified equipment, new or reworked product, systems, PLC's, and facilities. • Investigated returned product complaints and documented findings.• Provided technical training and assistance to other junior QE's. • Assisted in GxP related activities during plant shutdown operations.

• Performed environmental monitoring (e.g. air, surface, WFI / UP / DI / City water & product, personnel, steam, clean compressed air and return steam). • Assisted in sterility testing of final product. • Performed CAPA investigations of production incidences and performed trending. • Performed microbiological ID.

• Performed environmental monitoring testing. • Performed chemical (Gas Chromatography, FTIR, and HPLC) and microbiological (endotoxin and bioburden) testing on IOL's (IntraOcular Lense and components). • Performed 209E trending and completed related forms/reports..