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Street Address Wheeling Dr (919) 846-
Street Address (H)
Raleigh NC Street Address (919) 628-2449
(Cell)
EMAIL AVAILABLE
SENIOR QUALITY ASSURANCE / QUALITY ASSURANCE SUPERVISOR
Strategic Senior Quality Assurance with 18 years experience driving quality initiatives for regulated medical devices. Extensive
knowledge of GMPs, ISO, and FDA regulations. Experience includes Biotechnology, Pharmaceutical, and Hospital Laboratories.
Unique combination of expertise in clinical developmental, implementation of new products, logistics, Root Cause and Corrective
Action, cost reduction initiatives, continuous process improvement projects, statistical analysis of data, CAPA, GMP, GLP,
FMEA, SPC, and manufacturing areas. Additional competencies:
Raw Material/Product Testing PE/ Certified Six Sigma Green
Belt
Customer Data Management Product/Process Validation
Logistics Management Manufacturing Support
Operations Management Basic Statistical Analysis
PROFESSIONAL EXPERIENCE
PGC Consulting Agency, Allentown, PA 2010-Present
Responsible to support and assist clients with setting up, performing, and document supplier audits. Performed
supplier audit. Provide audit reports, presentations, charts, graphs, and appropriate documentation to the nature of
the services to be performed.
HOSPIRA, INC, Clayton, NC 2011-Present
Pharmaceutical/Manufacturing Medical Device Industry
Supervises quality assurance activities associated with production processes. Support and assists production to
identify needed improvements in processes and product quality. Evaluates and investigates deviations for
undesirable trends, ensures timely completion of investigations, writes reports and makes recommendations.
Coordinate and train Global Expansion personnel at India on Visual Inspection process.
BIOMERIUX INC, Durham, NC 2004-2010
Manufacturing Facility for IVD Medical Devices
Sr. QA System and Sr. Quality Engineer (Green Belt Certified)
Quality Engineering Support for Design Control Process Development and implement project Quality
Plan
Perform batch record review and statistical analysis of product released
Review and approve Design Specification, Design verification and Validation Protocols;
Provided assistance in regulatory submissions and issues by providing technical information and attending
project meetings as requested and/or appropriate .
Serve as Quality representative for supplier related team and improvement projects (i.e., the Supplier
Approval /Disapproval Committee, SEC, etc)
Develop quality engineering deliverables and assure Design History file (DHF) is updated;
Support the appraisal of the continuing effectiveness of the Quality Plan in terms of quality levels, nature of
manufacturing quality problems, customer complaints and supplier audits
Implement and /or recommend changes to procedures, policies, and specifications when appropriate;
Responsible for ensuring that the disposition non-conforming products meet all necessary regulatory
requirements and assure adequacy of corrective actions to prevent reoccurrence. Develop and establish
statistical trending analysis and training.
Establishes training modules as necessary for the quality system and associated programs
Managed the IVD Complaint Handling System and Nonconformance products.
Created and participated on product risk assessment team for all products within the product line.
Manage the nonconformance process for purchased parts and coordinate corrective action activities via the
CAPA system to ensure appropriate and timely supplier response
ORTHO CLINICAL DIAGNOSTICS, Johnson & Johnson Company, Raritan, NJ 1993 - 2004
Manufacturing Facility for IVD Medical Devices
Sr. Product Specialist (Engineer II) in Transfusion Medicine (1999 2003)
Served as liaison between Customers, Commercial Development, Technical Support and Marketing
regarding instrument reliability and service issues between Instrument Quality and Contract Manufacturers.
Maintained, developed, and reviewed field service procedures, standard test procedures, Service Bulletin,
Standard Operating Procedures and Medical Device regulations.
Diagnosed, resolved, and validated customer instrument and software problems.
Managed logistical issues within the Customer Technical Services Department (CTS).
Trained customers and Field Engineers in Medical Device/software procedures in accordance with 21 CRF
Part 11 and 820.
Implemented service and support for Immunohematology Systems for U.S. CTS.
Served as Service and Support Project Manager for Automated Provue Bloodbank instruments in the U.S.
Senior Quality Assurance Technologist (Team Leader) (1993 1999)
Supervised six laboratory technicians within the Quality Assurance Laboratory.
Organized, performed, tested and released raw materials, products, components, reagents and medical
analyzers.
Analyzed and prepared management reports to summarize data on stability program and customer complaints.
Prepared, revised, and approved validation procedures within the Quality Assurance Department.
Reviewed manufacturing production records (batch records), stability, and laboratory test results for
accuracy and compliance with GMPs and ISO9000.
Managed and maintained approximately $1 million of inventory within the QA department.
Completed validations, special projects, and product annual report for laboratory management.
Prepared and maintained monthly operation s schedule for Quality Assurance department.
Performed service and maintenance of laboratory instrumentations.
Developed and assisted in the development of new products, procedures and product specifications.
Conducted validation protocols for implementation of new instruments and new products.
VA MEDICAL CENTER, East Orange, NJ (Full Time) 1988 - 1993
Laboratory Services
Medical Technologist Generalist (Part Time) 1993 - 1998
Completed cell blood counts, differentials, sedimentation rates and manual hematocrits.
Performed manual tests on body fluids using the Hemacytometer and automatic/manual chemistry tests on
blood serum, urine and cerebrospinal fluid.
BETH ISRAEL MEDICAL CENTER, Newark, NJ 1989-1991
Laboratory Service for Cardiology and Pediatric Department
Medical Technologist Immunohematologist (Blood Bank)
Performed and processed routine complex serological procedures and special tests for antibody identification
and donors.
Processed platelets pheresis and directed donations in the Donor Service department.
UNITED STATES ARMY Rank-LTC (Retired) 1981-2009
Biological Chemical Nuclear Branch
Home land Defense Operations
Managed, trained, instructed, and managed various command and staff officer positions such as
Company Commander, Logistics Management Officer, Plans /Operations Management Officer, and
Battalion Commanding Officer for the North East Of U.S.
Managed, coordinated, and implemented Home Land Defense program in the Northeast of U.S.
Managed 750 personnel under my command
U.S Army Certified Instructor.
EDUCATION
BS in Biology with a minor in Chemical Technology, InterAmerican University of Puerto Rico
BS Medical Technology, University of Medicine and Dentistry, New Jersey
Command General Staff College MS, United States Army, FT Leavenworth, KS
SPECIAL SKILLS TRAINING
Process Excellence Green Belt Certification
Computer literate in Microsoft Word, Microsoft Excel, Microsoft Access, PowerPoint, Minitab, Lotus Notes,
MOVEX, JUMP, and Complaint Management System.
Statistical Process Control six Sigma and Quality Engineer courses.
Biochemical and Immunological techniques which include: Protein quantification, column chromatography,
and various electrophoresis procedures ( Immunoelectropheresis, electroimmunodiffusion, and PAGE) Karl
Fisher moisture training/Hazardous Material Certification,
Managing Personal Growth and Interpersonal Effect in Workplace and Individual Career Management
courses.
Master in Business Administration courses such as Marketing, Management, Economics, Production &
Operations Management and Financial Accounting (20 credits)
Language skills: English and Spanish
PROFESSIONAL ORGANIZATIONS
American Society for Quality Member, 1998-present
United States Army Reserve Officer Association Member, 1988 present
American Legion Chapter 1 1991- present
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