JOSE R. HERNANDEZ

**** ******** ** (***) ***-

**** (H)

Raleigh NC 27615 919-***-****

(Cell)

acfwj8@r.postjobfree.com

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:

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Raw Material/Product Testing PE/ Certified Six Sigma Green

Belt

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Customer Data Management Product/Process Validation

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Logistics Management Manufacturing Support

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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;

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Provided assistance in regulatory submissions and issues by providing technical information and attending

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project meetings as requested and/or appropriate .

Serve as Quality representative for supplier related team and improvement projects (i.e., the Supplier

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Approval /Disapproval Committee, SEC, etc)

Develop quality engineering deliverables and assure Design History file (DHF) is updated;

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Support the appraisal of the continuing effectiveness of the Quality Plan in terms of quality levels, nature of

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manufacturing quality problems, customer complaints and supplier audits

Implement and /or recommend changes to procedures, policies, and specifications when appropriate;

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Responsible for ensuring that the disposition non-conforming products meet all necessary regulatory

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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

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Managed the IVD Complaint Handling System and Nonconformance products.

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Created and participated on product risk assessment team for all products within the product line.

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Manage the nonconformance process for purchased parts and coordinate corrective action activities via the

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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.

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? 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.

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Performed service and maintenance of laboratory instrumentations.

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? 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

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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.

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Managed 750 personnel under my command

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U.S Army Certified Instructor.

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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

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Computer literate in Microsoft Word, Microsoft Excel, Microsoft Access, PowerPoint, Minitab, Lotus Notes,

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MOVEX, JUMP, and Complaint Management System.

Statistical Process Control six Sigma and Quality Engineer courses.

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Biochemical and Immunological techniques which include: Protein quantification, column chromatography,

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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

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courses.

Master in Business Administration courses such as Marketing, Management, Economics, Production &

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Operations Management and Financial Accounting (20 credits)

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Language skills: English and Spanish

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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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