SUMMARY:

• Consulting in Quality / Compliance 22 years as a quality & validation engineer assuming responsibilities as a lead/supervisor QE, project manager, quality assurance / control specialist, and business analyst in the Confidential / EMEA regulated industries (i.e. Pharma, Biotech, Medical Devices, Cosmeceutical and Neutraceuticals).
• Proficiency in compliance / standards with respect to Confidential 21CFR Part 111, 21CFR Part 211 (cGMP), 21CFR Part 58 (GLP), 21CFR Part 820 (QSR), 21CFR Part 11 ( Confidential ) & Annex 11, ANSI/ASQC Z1.4/Z1.9, ICHQ8, Q9 and Q10, EMEA GMP - 91/412/EEC & 91/356/EE, ISO 9000, 9001, 9002, ISO13485, ISO TC 209-14698, ISO 14644, EN45001 / ISO17025, IEC 62304, 60601-1, ISO 14971, MIL-STD-1629A, and ASTM E2500.
• 20 years experience authoring, revising, approving, executing and reporting validation protocols for Computerized Systems, Equipment, Process, Facility/Utility, Test Methods, and Cleaning.
• 18 years experience developing SDLC documentation and deliverables per ISPE GAMP5 Waterfall methodology and software & electro-mechanical device development using Agile / SCRUM methodology.
• Skilled with DOE’s, applying 6sigma / SPC / SQC / TQM methodology, and gage R&R.
• Experienced in conducting / auditing CAPA / IR / DR / OOS / OOT of systems / processes and resolving challenges utilizing FTA / Confidential (with emphasis on device / product, process, and methods).
• Experienced in project management, strategically performing assessments, providing detailed & executive summaries, developing: project charters, project plans, master validation plans, progress metrics, final reports, and providing recommendations.
• Experienced in managing a project budget, hiring / training employees, resolving issues / conflict, prioritizing project items / resources based on risk & effectiveness, and keeping a dynamic project based on regulatory/management needs.
• Experienced in team building, consulting, and training with respect to validation methodology, compliance, regulations, and quality engineering.

TECHNICAL SKILLS:

Applications: MS Office (Access, Excel, Word, Power Point, Outlook, Project, Visio), Crystal Reports, MiniTab, Statgraphics / Centurion, Statistica, BM CalMAN, Trackwise, SQL Server Mgmt Studio, CATsWeb, Quality Center v10, Test Director, QNX, LabView.

MES: Wonderware, Allen Bradley, Rockwell, Siemens, Lighthouse.

EDMS: MetaPhase, Documentum, Content Management System (TevaDoc), PLM (Agile and IBM PDM).

CDS/SDMS: Waters Millennium and Empower, Masslynx, Chemstation, Chromeleon, Waters Confidential, Labware LIMS, NuGenesis.

ERP/MRP: SAP R/3, MfgPRO, various Oracle based ERP systems, and Solidworks ERP module.

Databases: SQL, Oracle, MS Access.

Languages: English and Polish (native), Spanish and French (conversational)

PROFESSIONAL EXPERIENCE:

SAP Validation Consultant

Confidential, Valencia, CA

Responsibilities:

• Applying Agile methodology in the development of User Stories and Test Scripts for Logistics and Planning modules.
• Reviewing and editing Design Specifications for LO, PL, CS and other modules.
• Reviewing and notifying team of inconsistencies and omitted components in Micros while tracing to Macros and test scripts.
• Reviewing JIRA SAP ticket system and verifying consistency / traceability throughout the SDLC documents.
• Working with team to develop and adjust Micro’s as needed.

Validation Consultant

Confidential, Pasadena, CA

Responsibilities:

• Generating Master Validation Plan.
• Reviewing mechanical, electrical, plumbing, cleanroom, process gases, architectural, IT Infrastructure, ESD and EH&S design specifications against facility layouts / plans. Providing instructions for corrections and as-is verification.
• Generating / executing facility, utility and equipment validation documentation.

Validation Engineer Consultant

Confidential, Foster City, CA

Responsibilities:

• With respect to Lab Systems, responsibilities consist of SDLC activities per GAMP5, 21 CFR Part 11 and Annex 11:
• Assessing 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.
• Providing technical/regulatory comparison of Empower 3.5 vs. Chromeleon 7.2 to management.
• Performing Risk Assessments.
• Supporting change control activities.
• Assessing computerized system relevant SOP’s, including Administration, Use, Backup / Archiving, Decommissioning, and Periodic Review.
• Consulting 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.
• Supporting the development of User Acceptance Testing.

Quality Engineer Consultant

Confidential, Irvine, CA

Responsibilities:

• Performing Confidential analysis of current validations to assess whether they meet corporate, divisional, and regulatory requirements, while aligning with industry standards.
• Assessing Software Validations.
• Assessing deficiencies in existing documents which included Manufacturing Plans, Quality Plans, Test Method Validations, Design Specifications, Design History File, OP, IOQ, PQ, and Process Validations.
• Providing detailed and executive report of audit findings to executive management.
• Preparing client site for corporate audit.

CSV Consultant

Confidential, Irvine, CA

Responsibilities:

• Assessing and performing audit of Computerized Systems, mainly Chromatography and general Lab Systems: (e.g. TGA, DSC, TOC, HPLC, GC, LIMS, etc) which include software such as Dionex Chromeleon, Zetasizer, Agilent/Varian, for 21 CFR Part 11 (P11) / GAMP5 compliance.
• Generating report(s) and plan(s).
• Generating relevant documentation to remediate gaps with respect to P11 regulations and GAMP5 standards.
• Consulting / advising on strategies to mitigate non-compliance.
• Administration / modification of system settings, to comply with P11.
• Generating Remediation Plan / Document.
• With the expertise of Technical Owner, SME, and external consultant, administrating / modifying system security and audit trail settings.
• Generating SDLC relevant documents, as needed, per GAMP5 and P11.
• Providing Training to employees with respect to data acquisition and P11 compliance requirements .

Quality Engineer Lead Consultant

Confidential, Irvine, CA

Responsibilities:

• Directing a team of quality engineers in product integration project.
• Generating Quality and Process / Equipment / Design Validation procedures / procedures / policies.
• Generating dFMEcA and pFMEcA for stent product of an acquired stent manufacturer, “Reverse Medical”.
• Performing Confidential 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.
• Improving and creating inspection points / test methods.
• Reviewing / commenting / training of QEs and MEs on drafting of QP and MP SOP’s.
• Generating Gage R&R and Test Method Validations including Test Method Validations.
• Training engineers and generating various tool / test fixture Feasibility, Engineering, and DOE studies.
• Improving and bringing compliance to an existing process.
• Migrating a fully manual process into semi-automated operation.
• Developing a training program and training operators, inspectors, and QC leads / supervisors.

Validation Engineer Consultant

Confidential, Newark, DE

Responsibilities:

• Authoring IOQ and PQ protocols / test cases for Korsch and Stokes tablet presses and granulators including Allen Bradley PLC, Wonderware Confidential interface.
• Developing and performing Process Characterization protocols for tableting process.

Quality Engineer / Project Manager

Confidential, Santa Ana, CA

Responsibilities:

• Generated compliance Confidential assessment on process, CatsWeb SQL database and SAP per Confidential and other global governing agencies, local site, AMO global, and divisional policies and regulations with respect to product safety & compliance metrics (i.e. Post Market Surveillance, Adverse Events, MDR, monthly, quarterly, and annual regulatory agency submission).
• Generated detailed compliance and technical assessment, reports, and executive summary to management.
• Created 21 CFR Part 820 / ISO 13485 (GxP), 21 CFR Part 11 / Annex 11 (electronic records and electronic signatures or Confidential ) compliance Confidential remediation plans and risk assessment, which included implementation and integration with existing technology (i.e. SAP Business Intelligence / Business Objects and Web Client).
• Revised / created procedures and validation SOP’s to comply with divisional policy and GxP / Confidential .
• Revised existing process and validation SOP’s to comply with GxP, Confidential, global, divisional policy.
• Generated technical Work Instructions (WI) for Adverse Event (AE), MDR, quarterly and annual product safety / complaints trending and data acquisition process between CatsWeb and SAP.
• Tracked and reported on progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
• Managed activities to resolve project issues with team members and project stakeholders: subject matter experts (SME’s), Business Owners (BO’s), and Technical Owners (TO’s).
• Authored / executed validation and verification documentation, GAMP5 SDLC documentation and reported on activities / deliverables pertaining to product trending systems/processes.
• Trained team on strategies for improved trending accuracy between CATSWeb and SAP.

Quality Systems Engineer / CSV Consultant

Confidential, Irvine, CA

Responsibilities:

• Authored Requirement Specifications and Test Scripts for Confidential Forms in Quality Center v10 and resolved associated deviations in QC and Confidential .
• Authored associated SDLC documentation: Validation Master Plan (VMP) and Validation Summary Report (VSR).
• Trained technical owner on GxP / Confidential requirements and testing scripts.

Quality Systems Engineer

Confidential

Responsibilities:

• Maintained and assured compliance of current / new Computerized & Automated Systems, per local / global policies, SOP’s, regulatory agencies:
• Assured the compliance of businesses, functional and user requirements with respect to system, procedural, interface, data, business, and regulatory requirements (please see note at end of this section for detailed list.)
• Cultivated communicative rapport with management and executives across QC / R&D Laboratories, RA, IT Compliance, Engineering, Operations / Mfg, Facilities, Maintenance and Metrology (local site and global).
• Ensured the completion and approval of the Software Development Life Cycle phases (SDLC) deliverables for all departments (as stated above), the validation status, approval for system release with respect to implementation and maintained compliance of the system’s validated state after release.
• Led meetings to provide QA SME guidance with respect to site, global, and regulations.
• Identified and resolved issues by employing criticality, risk / severity analysis, and regulatory / business requirements.
• Documented activities issues, severity, risk/severity, and provided progress / issues / action plan reports to upper management.
• Trained users and stakeholders on GAMP process, procedural and site / global policies, change control, spreadsheet validation requirements, authoring of SDLC documentation, etc.
• Developed, revised, edited, and implemented validation policies and SOP’s ( Confidential, Lab Systems, and Equipment Engineering Controls) pertaining to Lab System Assays / Methods, Change Control, System Administration, Maintenance, and Calibration.
• Additional responsibilities consist of:
• Supported validation of product, equipment and process as it relates to review of data, and analysis. Supported data collection, analysis and reporting to identify and then optimize the most important parameters affecting product quality and support implementation of CAPA and Root Cause Analysis (RCA) as it relates to DR, complaints, IR, observations and OOS.
• Revised / approved Admin, Use, Method, Assay, Instrument, and contingent SDLC SOP / WI’s.
• Supported Internal / External Regulatory Audits as a Computerized System QA SME.
• Supported internal and agency audits and inspections of computerized systems.
• Addressed, reported and mitigated observations identified during these events.
• Generate remediation plans as needed.
• Reviewed, commented, and approved Change Requests in TrackWise for Critical & Non-critical System Change Requests within Engineering Controls, Lab, and Enterprise Systems.

Computerized Systems Validation Consultant

Confidential

Responsibilities:

• Authored Laboratory Systems / Instruments and Engineering Controls SDLC documents (VMP, FDS, URS, SCS, IQ, OQ, PQ, TM, VSR, Admin SOP, Change Management documents) and executed test scripts.
• Performed periodic review (PR) of software / system, Confidential assessments and generated reports (4).
• Revised and assisted in creation of SOPs with respect to Use, Administration, and Maintenance.

IS Quality Validation Engineer

Confidential, Valencia, CA

Responsibilities:

• Developed SDLC documentation, assessed systems per Confidential, and generated Baseline, and Intended Use documents.
• As part of the remediation process, generated or revised any missing SDLC documentation (DS, URS, System Req., IQ, Test Scripts, SOP’s, Manuals, and TM).
• Procured Retirement Plans, data migrations, and disposition of software and hardware.
• Generated reports on the above mentioned.

Quality Engineer

Confidential, CA

Responsibilities:

• Authored V&V validation protocol, TM, RA, and GUI & Integration test scripts for the Intra-Optical Aberrometer.
• Executed test scripts and generated reports

Business Analyst / Quality Engineer

Confidential, Thousand Oaks, CA

Responsibilities:

• 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 input on quality resources and budget requirements.
• Chaired review meetings with executives / stakeholders to mitigate gaps / inconsistencies within resourcing and budgeting.

SAP Validation Engineer

Confidential, Irvine, CA

Responsibilities:

• Developed SDLC documentation for validation of SAP modules.
• Development of blueprints, landscape design, technical architecture, system requirements specifications, FDS, RA, TM, unit / integration test scripts and 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.
• Audited WLAN, RF site survey and stress testing scripts, executed and generated reports.
• Developed, maintained, and tracked validation deliverables.

Alternate Material Quality Engineer

Confidential, Irvine, CA

Responsibilities:

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

Quality Engineer

Confidential, Irvine, CA

Responsibilities:

• 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

Confidential

Responsibilities:

• Authored / executed assembly equipment (e.g. cone adhesive system), facility / utility, and process validations.
• Executed equipment, test methods and Confidential compliance audit.
• Prepared safety, chemical storage, and industrial hygiene assessments / reports.