SUMMARY:

• My broad experience includes more than 20 years’ experience as a Program Manager/ProjectManager and several years of Legal Compliance/Government Affairs work, including GxPs and toxic substances.
• My continuing education and experience include completion of: Customer Service Training Programs, Continuous Quality Improvement Programs, ISPE Aseptic Facility Design & Construction, Computer Systems Validation (including Enterprise, Control Systems, and LIMS) Projects, and the UCSD Drug Discovery/Quality Management Systems Courses.
• My experience includes successfully managing multi - million dollar project assignments to completion: both on schedule and within budget.
• Additionally, I have performed as a team player and individual technical contributor on some highly specialized engineering assignments.
• My written and oral communications skills have been highly complimented on several occasions, and I believe that good communications are the key to success in any position.
• Expertise in the management of engineering projects, validation, contract management, control systems, total quality management, deliverables, GA MP Guidelines, and Confidential regulations’ (21 CFR Parts 11, 58, 210, 211, 820, etc.) & Guidance, and ISO 13485 compliance; Agile and Scrum Methodology expertise.

TECHNICAL SKILLS:

SOFTWARE: Documentum, Allen-Bradley Logix, Sharepoint, Clarity, OpenWorkbench, MS Project, Pilgrim Smartsolv/ CAPA, MS Office, SAP Var. Modules (PM,MM,QM,PP,PS), Peregrine EDI S/W, Minitab, Master Control, Trackwise, Crystal Reports, MES Systems - including Wonderware and OSI, SAS, PDM (Windchill), Datastream 7i, DeltaV, Emerson AMS, Confidential LIMS, HP/Mercury Quality Center Software, Livelink.

HARDWARE: Confidential System/370+, EDI Exchange, Foxboro Videospec, Microspec, Honeywell TDC 3000, Yokogawa Micro XL, Centum CS, Yokogawa XL-Net, Emerson Provox + DeltaV, Allen-Bradley PLCs, Andover Controls BMS.

EXPERIENCE

Confidential

Validation Contractor

Responsibilities:

• Performed validation QA reviews and oversight of Items/Documents related to Confidential ’s Systems Migration to the Internet Cloud.
• Performing SAP Systems validation/verification/validation strategy development, planning, resource-loading, and scheduling tasks.

Confidential

Project Manager

Responsibilities:

• Performed management and oversight of Recipe & Research Big Data collection, compilation, masking, encryption, and submission to Confidential for Confidential Proof-of-Concept Study. Performed Study verification/validation strategy devel., planning, resource-loading, and scheduling tasks.

Confidential

CSV Team Lead

Responsibilities:

• Performing management and oversight of validation activities required for compliance with the new Confidential Unique Device Identifier (UDI) Regulations on a corporate-wide basis.
• Utilized Agile Methodology for S/W strategy devel., planning, resource-loading, tasks/devel.

Confidential

Sr. Consultant

Responsibilities:

• Performed manufacturing systems validation documentation remediation at a large titanium, stainless steel, and PEEK materials body-implant manufacturing facility.
• Documented the UDI-required software changes needed to etching and labeling equipment/devices.

Confidential

Sr. Consultant

Responsibilities:

• Performed computer systems validation planning, documentation, layout and protocol generation/execution and Project Management for Research & Development Systems at a large manufacturing facility in Indiana.

Confidential

Sr. Consultant

Responsibilities:

• Performed GAMP5-coordinated automated systems design, installation, execution, and validation Project Management, Design Contractor oversight, and Validation Training of employees.

Confidential

Sr. Consultant

Responsibilities:

• Performed manufacturing/labeling/packaging line analysis/documentation; under Consent Decree performed process validation planning.
• Produced a labeling/packaging line validation upgrade project plan.

Confidential

Sr. Consultant

Responsibilities:

• Performed systems review, execution, and implement. of SAP/QM + Trackwise SDLC Validation docs: VP, IOQ, PQ, TM, and Report.

Confidential

Project Manager

Responsibilities:

• Performed Project Management, Validation Planning Management, and WBS setup for implementation of the Confidential LIMS system at Confidential .
• Conducted validation training sessions for Shire Laboratory Subject Matter Experts (SMEs).

Confidential

Sr. Validation Consultant

Responsibilities:

• Reviewed/updated corporate validation methodology SOPs.
• Prepared/QA reviewed all validation life cycle documents (VP, URS, FRS, SDS, TM) for Laboratory Instruments and Complaints Handling Department strategic Spreadsheets and Databases.

Confidential

Project Manager

Responsibilities:

• Performed MES/Manufacturing Control Systems project management, WBS design, quality reviews and assessments, and financial control for new DeltaV + AMS control systems in a new-construction Titanium Plant and an upgraded Dissolvable-Paper Mill Prods. project.
• Utilized Oracle, Clarity, and Open Workbench Suite for back-office budgeting, scheduling, profit projections, and reporting.

Confidential

Sr. QA Consultant

Responsibilities:

• Performed quality reviews of all project data for qualification, documentation, and testing/maintenance of MDS’ worldwide Clinical Data Network; document mgmt. system upgraded.
• Servers were documented and validated to Confidential, high-level standards as well.

Confidential

Sr. Validation Consultant

Responsibilities:

• Developed the validation master plan documents for fast-track validation of Empower 2 HPLC System.
• Performed QA review of key validation life cycle documents (VP, RA, SDD, TM).
• Performed review and management of documents in Trackwise System.

Confidential

Sr. Validation Consultant/Project Manager

Responsibilities:

• Developed the Validation Master Plan for fast-track validation of SAP’s new All-IN-One System, which included HR, FICO, Supply Chain, and Inventory.
• Performed QA review of all validation life-cycle documents (VP, URS, FRS, SDS, TM). Wrote the Project Plan.

Confidential

Sr. Validation Consultant/Project Manager

Responsibilities:

• QA reviewed all validation life cycle documents (VP,URS, FRS, SDS, TM) for a new CAPA System.
• Performed SQA activities/tasks regarding SOPs, for SAP QM Module, SAP MM, and Datastream 7i Implementation, via Windchill PDM. Re-wrote the Datastream 7i Maintenance Management Project Plan, Schedule, Quality Plan, and Testing Plan.

Confidential

SAP M&E Team Lead

Responsibilities:

• Performed planning, documenting, training, and oversight of the SAP FI/CO Modifications & Enhancements implementation work processes, for Order-to-Cash + P2P area transactions - including test documentation/verification, per GAMP4 SDLC Guidelines.

Confidential

Sr. Validation Consultant/Project Manager

Responsibilities:

• Worked on implementation and validation of a new Electronic Product Release Process, which included new QM Module Implement., Materials Management, Inspections, Supply Chain, and Inventory functions.
• QA reviewed all levels of validation life cycle documents (VP, RA, URS, FRS, SDS, TM) related to the manufacture of BSCI medical devices: catheters, balloons, and endoscopes, utilizing enterprise-wide Windchill PDM Sys.
• Completed manufacturing station calibration specifications at automated production line.
• Developed Validation Master Plan for new line of endoscopic devices.
• Validated Minitab EDC Sys. Conducted daily project review meetings coordinated with the Project Management Office.

Confidential

Sr. Validation Consultant/Project Manager

Responsibilities:

• Performed Laboratory Instrument & Analytical Device Sys. validation assessment and project planning activities.
• Developed life cycle documents (VP,URS, FRS) in accordance with GAMP 4 guidelines.
• Reviewed documents for compliance with electronic records management regulations and GLP/GMP practices.
• Utilized Documentum for document reviews and management.

Confidential

Sr. Validation Consultant/Project Manager

Responsibilities:

• Performed SAP Systems validation QA project planning activities, and review of validation life cycle documents (VP,URS, FRS,IQ,OQ test plan/test scripts) generated performed QA review of documents for the PM, QM, and MM module implement.

Confidential

Sr. Validation Specialist/Project Manager

Responsibilities:

• Performed SAP Systems validation project planning activities, and validation life cycle documents (VP,URS,FRS,IQ,OQ test plan/test scripts) generation per GAMP 4 guidelines; performed QA review of documents for the PM, PS, and MM modules as part of a huge SAP Validation Project.
• Reviewed documents for compliance with electronic records management regulations.

Confidential

Computer Validation QA Consultant

Responsibilities:

• Performed Manufacturing Systems QA Validation document reviews and assessments, at Confidential as part of a major BMS/DCS/PLC validation upgrade project.
• Developed and reviewed Test Case procedures + documents in Trackwise.