SUMMARY
Expertise in the management of engineering projects, program management, validation, contract management, control systems, total quality management, GAMP, and FDA regulations’ (21 CFR Parts 11, 58, 210, 211, 820, etc.) and ISO 13485 compliance.

EXPERIENCE
Consulting Assignments: [09/96 – Present]
2010 -- RECENT TEMPORARY ASSIGNMENTS:

• Validation Specialist -- Winding up a rush Lab. Instr. Remediation Validation assignment at Confidential,
• Proj. Mgr. -- Completed a Validation Project Plan assignment RE: Central Doc. Mgmt Sys. At Confidential.

Confidential, (04/10 – 05/10)
Sr. Project Manager
Prepared SSRC/STS Data Center Consol. Charter & Project Management Plan with achievable cost, schedule, and goals; Dash-board; managed project risks and issues, project cost, schedule and scope

Confidential, (09/09 – 12/09)
Sr. Validation Consultant
Prepared/QA reviewed all validation life cycle documents (VP,URS, FRS, SDS, TM) for Instron Instruments (utilized to test stent strength of materials) and Complaints Department strategic Spreadsheets and Databases.

Confidential, (02/08 – 03/09)
Project Manager (FTE)
Performed Manufacturing Control Systems project management, 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 Products project.

Confidential, (09/07 – 02/08)
Sr. QA Consultant
Performed quality reviews of all project data for qualification, documentation, and testing/maintenance of MDS’ worldwide Clinical Data Network, including regional server clusters. Servers/virtual servers were documented and validated to FDA, high-level standards as well.

Confidential, (07/07 – 08/07)
Sr. Validation Consultant
Developed the validation master plan documents for fast-track validation of Empower 2 HPLC System, and integration to site-wide LIMS. Performed QA review of key validation life cycle documents (VP, RA, SDD, TM) related to software quality assurance activities (SQA).

Confidential, (03/07 – 05/07)
Sr. Validation Consultant/Project Manager
Developed the Validation Master Plan for fast-track validation of SAP’s new All-IN-One System. Performed QA review of all validation life-cycle documents (VP, URS, FRS, SDS, TM) related to software quality assurance activities (SQA). Wrote Project Plan.

Confidential, (03/06 – 12/06)
Sr. Validation Consultant/Project Manager
QA reviewed all validation life cycle documents (VP,URS, FRS, SDS, TM) for a new CAPA System. CAPA
Emmitt E. Griffie Page -2
requirements were met for design, mfg., and performance of stents, etc. Performed SQA activities/tasks regarding SOPs, for Electronic Product Release (SAP QM Module), SAP MM, and Datastream 7i Implementation. Re-wrote the Datastream 7i Project Plan, Schedule, Procedures, Validation Master Plan, Quality Plan, and Testing Plan.

Confidential, (11/05 – 03/06)
SAP M&E Team Lead
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, (01/05 – 10/05)
Sr. Validation Consultant/Project Manager
QA reviewed all levels of validation life cycle documents (VP, RA, URS, FRS, SDS, TM) related to the manufacture, packaging, and testing of BSCI medical devices: catheters, stents balloons, and endoscopes. Completed manufacturing station calibration specifications for automated production line. Developed Validation Master Plan for new line of endoscopic medical devices (Endovations System), including a LIMS interface. Conducted daily project review meetings for a portfolio of fast track projects; coordinated with the Project Management Office.

Confidential, (08/04 – 11/04)
Sr. Validation Consultant/Project Manager
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,(03/04 – 08/04)
Sr. Validation Consultant/Project Manager
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, utilizing GAMP 4 recommendations as guidelines; performed QA review of documents for the PM, QM, and MM modules as part of a large SAP Validation Project.

Confidential, (08/03 – 12/03)
Sr. Validation Specialist/Project Manager
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.

BAYER PHARMACEUTICAL (02/03 – 08/03)
Computer Validation QA Consultant
Performed Manufacturing Systems QA Validation document reviews and assessments, at Bayer (Clayton, NC) Blood Plasma Processing plant as part of a major process control systems (BMS/DCS/PLC) validation upgrade project. Developed and reviewed Test Case procedures and documents in an enterprise EDMS.

Confidential, (09/02 – 01/03)
Business Consultant
Prepared the Validation Master Plan (and Schedule), IQ, OQ, and PQ documents for the validation of an upgraded, networked, Building Management System (BMS).

Confidential, (08/00 – 07/02)
Project Manager (FTE)
Managed a large Bill Payment virtual implementation project; conducted thrice-weekly customer meetings. Was
project manager for rush development of Bank of America’s P2P payment system, in accordance with CMMS Guidelines.

Confidential, (09/99 – 01/00)
Project Manager
Completed the project management of a successful Y2K business continuity planning assignment. Also, updated the Admin. Off. of the Courts’ business continuity procedures.

Confidential, (05/99 – 09/99)
Project Manager (FTE)
Completed the management software implementation processes and Y2K software remediation IV/V assessments for the NYS’ “Top-Priority Systems” in a $1 million-per-month effort. Reviewed, oversaw, and monitored assessment report development efforts of 20 senior consultants. Authored the Final Report which was sent to the Governor of New York State.

Confidential, (09/96 – 03/99)
Control Systems Group Manager (FTE)
Managed two major client-server network installations. Co-managed a $4 million SAP implementation project (HR, FI, MM, PP-PI modules). Also, produced an Enterprise-wide automation master plan, which included a LIMS network design.

EDUCATION
· B.S. Degree in Chemical Engineering
· M.S. Degree in , Engineering Management (Operations Research)
· M.S. Credits in Physiology of Biomedical Processes
· M.S. Certification in , Pharmaceutical Engineering
· M.B.A. Credits in Project and Construction Management
· J.D. Credits in Business Law (Contracts, Legal Writing, U.C.C.)

SOFTWARE:
Allen-Bradley Logix, Primavera, Timeline, dBASE, Smart, SAS, Microsoft Project, Pilgrim CAPA, MS Office, SAP Var. Modules (PM,MM,QM,PP,PS), Peregrine EDI S/W, Ross Sys., Minitab, MasterControl Compliance S/W, Documentum, Trackwise, Crystal Reports, PDM (Windchill), Datastream 7i, Emerson Asset Mgmt. (AMS).

HARDWARE:
IBM System/370+, IBM MQ Series, DEC VAX, EDI Exchange, Foxboro FOX1, FOX2, Foxboro Videospec, Microspec, Honeywell TDC 2000, TDC 3000, Yokogawa Micro XL, Centum CS, Yokogawa XL-Net, Emerson Provox + DeltaV, Allen-Bradley PLCs, Andover Controls Building Management Systems.