Edgard L. Ram rez

*** **** ***** ******, *** *C, NY NY 10040

787-***-**** // abhrhb@r.postjobfree.com

Summary of Qualifications

Five years of experience as a Professional in the Pharmaceutical Medical

Device Industry. Quality Assurance Auditor responsible to assure compliance

with all Federal, State, and FDA regulations, Corporate, Policies,

Procedures and Protocols. Accountable for enforcing the federal

regulations and guidance. Interpret and update standard operating

procedures and deploy information. Organized, reliable with outstanding

interpersonal and communication skills. Computer knowledge in Microsoft

Office (Word, Excel, Power Point), Minitab and Internet. Bilingual:

English and Spanish.

Accomplishment

. Contributor of site recognition as one of the Best Companies in the

Pharmaceutical sector by Pharmaceutical Magazine in 2009

. Contributor of site selection by J&J over Latina & Scotland to

manufacture the UBD product for Japan.

. Contributor of Batch Record Auditing Cycle Time reduction from 21 to 3

days for Bx, UBD, Select & X-tend.

Professional Experience

Johnson & Johnson Cordis LLC, San Germ n, Puerto Rico

2004 - 2010

Quality Assurance Auditor

. Interpret, and understand written procedures. (SOP's, OP Sheets,

Drawings, Engineering Specs).

. Interface with peers, supervision, engineering and management

professionally and respectfully.

. Assured that all documentation was presented, completed and correctly

issued, properly documented and guaranteed compliance with QSR, GDP,

cGMP, production and manufacturing procedures. (i.e. Calibration

Sheets, WIP Cards, Coating Forms and Router).

. Supported different investigation projects and special assignments as

required.

. Ability to follow-up on process which involve multiple departments

while paying attention to details.

. Interfaced with other departments to ensure business needs were met.

. Identified potential issues using problem solving and decision-making

techniques to address them.

. Responsible for detecting non-conformances, generate the NCIF and

segregate product according preliminary and/or final disposition,

ensuring proper physical location and identification.

. Reviewed, evaluated and made prompt decisions to solve or address the

on-line discrepancies.

. Performed system transactions to assured proper tracking, closing and

approval of lots in the MES and JDE system as needed.

. Responsible for the finished good closure quantity integrity, proper

labeling, and transportation inside and outside clean room prior to

lot release, to its designated location.

. Ensured personnel and peer adherence to all applicable FDA, ISO,

State, Local, Company, Health Safety and Environmental Policies.

. Recipient of many Encore Awards, J&J On Law School Online and

ENDUNEERING online Courses

San German Mare House / Public Projects Department

2003 - 2004 Heavy Truck Driver

. Deliver of different materials in a Dump Truck to the designated

working area.

. Coordinate with Supervisor and crewmembers to perform on a time

efficient basis.

. Make decisions to enable the group to work with minimum supervision.

Digital Planet Communications Inc., Ponce, Puerto Rico

2003 - 2004

Sales Representative

. Sold variety of contracts along with acquisitions and payments

options.

Empresas Bechara Inc., Mayag ez, Puerto Rico

2002 - 2003

Front Clerk at Hotel El Sol

. Interface with peers to assign daily labors and work with computers

and fax machines.

. Attendance phone calls and customers, assuring accurate checks in an

out in both languages.

. Coordinated dates, room types, rates, availability and room status

with the housekeeping report.

. Responsible for the money and credit card accountability during shift

and the night audition report.

Suiza Dairy Corporation, Aguadilla, Puerto Rico

1991 - 2002

Sales Agent

. Salesman representing Suiza Dairy Corporation; designated for

personal, business and credit accounts.

. Sale a wide variety of Dairy products and Suiza Fruit Trade Marks by

using Handheld Computers.

. Responsible for the inventory availability and the on time deliveries

driving an F-700 Refrigerated unit.

Education

Interamerican University, San Germ n, Puerto Rico

1980 - 1986

Bachelor in Science, Biology Mayor, Chemistry Minor

Trainings

. Human Error Investigation

. ValueStreamMapping / Poka - Yoke

. Product Non-Conformance Process & Control of Nonconforming Products

Policy

. Workstation Practices / MES Procedures / GDP / GMP / Shipping

Procedure

. FDA Readiness Training / FDA Inspection Training & Auditing Principles

. Chemical Compatibility-Awareness Training

. IAPP Information Asset Protection Policy & IT Information Security

Policy

. Identification, Segregation and Controlled Handling of Nonconforming

Products

. Corrective and Preventive Actions - CAPA

. Mechanics of Safety / Lock Out Tag Out / Electrical Safety

. Lean Manufacturing; The 8 Waste Knowledge

. Yellow Belt Training / Process Excellence Overview

. FDA Regulations for The Pharmaceutical Industry, ISO 9000, ISO 14000,

OSAS 18000

Contact this candidate