Quality Assurance Medical

JOSE RAUL HERNANDEZ

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

**** (H)

Raleigh NC 27615 919-***-**** (C)

************@**.**.***

MANUFACTURING QA SUPERVISOR / PACKAGING 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, and 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

Lead Auditor

Responsible for support and assist clients with setting up, performing, and document supplier audits.

Perform and provide supplier 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

Manufacturing Quality Assurance Supervisor

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.

Observes packaging operations and inspects containers to verify conformance to specifications.

Inspects products prior to packaging and returns rejected products to production departments.

Performed and certified packaging inspector in Visual Inspection at Vizag India.

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

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 in the manufacturing

process. Develop and establish statistical trending analysis and training.

Establishes training modules as necessary for the quality system and associated programs

Supervises and coordinates activities of workers engaged in packaging products and materials for storage or

shipment: Studies production order to ascertain type and quantity of product, containers to be used, and other

packaging requirements. 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, Raritan, NJ 1993-2004

Johnson & Johnson Company, Manufacturing Facility for IVD Medical Devices

Sr. Product Specialist (Engineer II) in Transfusion Medicine 2000-2004

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

Medical Technologist Generalist (Part Time) 1993 – 1998

Assistant Supervisor

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.

Provided training for new medical students and laboratory personnel

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 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

Master in Science in Manufacturing Quality Assurance

University of California Dominguez Hills (28 credits)

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, SAP,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 1991- present

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