Quality Assurance Control

Summary of Qualifications

Highly motivated and results-oriented Medical Technologist Professional,

possessing exceptional clinical and industrial laboratory skills.

Demonstrated ability to streamline operations to increase efficiency and

company profit. Strong background in cross functional laboratory

management that enhances market share and revenue base. Solid track record

of exceeding corporate goals through strategic planning, business

expansion, and project execution.

Highlights

Medical Technologist ASCP, MT license number 6124.

In-depth knowledge of laboratory techniques and equipments.

Knowledge in EPA, CLIA, OSHA and department of health of Puerto Rico

regulations.

Excellent computer and statistical skills.

Work well in a high pressure environment.

Effective and productive worker independently or as a team member.

Fully bilingual (Spanish and English).

Skilled at organizing complex projects, defining project priorities, and

delegating tasks.

Self-starting, goal-oriented strategist whose confidence, perseverance and

vision promote success.

Quickly learn procedures and methods.

Demonstrated ability to consistently meet deadlines.

Capable of handling multiple projects concurrently.

FDA approved batch record review certificate.

Professional Experience

Schering-Plough Products, LLC - Manati, Puerto Rico 2001 - 2003

Quality Assurance Product Disposition Specialist

. Perform audits and review batch records regarding final product &

dosage.

. Assist internal inspectors on the material release process.

. Train the majority of the newly hired quality assurance product

specialists.

. Verify all the chemistry and microbiology raw data.

. Refer and execute internal investigations.

. Review and/or modify standard operations procedures.

. Generate variance reports.

. Final approval of all the products batch (Certificate of Analysis).

Ashford Medical Clinical Laboratory - Hato Rey, Puerto Rico 2000 - 2001

Medical Technologist

. Phlebotomy.

. Performed Laboratory Sampling.

. Performed Quality Assurance and Quality Control.

. Accomplished RIA, ELISA and Western Blot Tests.

. Acquaintance in VITEK 500, COULTER, HITACHI, and others.

Schering-Plough Products, LLC - Toa Alta, Puerto Rico 1998 - 2000

Pharmaceutical Sales Representative

. Responsible for marketing of the Schering-Plough's Essex Division

products on the eastern region of Puerto Rico.

Education

Interamerican University of Puerto Rico - San Juan, Puerto Rico 1990 -

1992

Associate Degree in Management (Major Accounting)

Interamerican University of Puerto Rico - San Juan, Puerto Rico 1992 -

1996

Bachelor's Degree in Biology (Major Microbiology)

Interamerican University of Puerto Rico - San Juan, Puerto Rico 1996 -

1998

Bachelor's Degree in Medical Technology

The School Medical Technologists of Puerto Rico (CTMPR) - San Juan, Puerto

Rico 1998

ASCP, MT License 6124

Certifications

FDA Approved Batch Record Review

Electronic Common technical document (eCDT)

Computer Literate: Microsoft Office 2000, PRISM & LIMS System

Knowledge in FDA regulations cGMP, GMP's, SOP's revision and Implementation

Professional Designation in Critical Trials Management

Professional Designation in Good Clinical Practice

GMP Clinical Trial Monitoring: Site Evaluation and Set -Up

GMP: Preparing for an Audit or Inspection

Professional Designation in Good Manufacturing Practice (GMP)

Professional Designation in Microbiology and Good Manufacturing Practices

(GMP)

GMP: Microbiology in the Workplace

GMP: Cleaning and Sanitation

GMP: Documentation and Record

GMP: Quality Assurance and Quality Control

GMP: Product Controls

Train of Trainers Courses

Technical Writing Courses

Investigation Reports Courses

Professional Designation in Quality Control in the Laboratory (GLP's)

Professional Designation in Microbiology Lab Techniques and Quality Control

GLP: QC in Regulated Laboratory

Statistic for QC Laboratories

GLP Quality Control: Analytical Method Validation

Professional Designation in Electric Signature & Records

Excel Spreadsheet and FDA Device Regulation

21 CFR Part 11: How to Successfully Prepare for Host an FDA Inspection

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