Quality Assurance Six Sigma

Luis Miguel Vega Barreto

*** ***** **.

San Antonio, TX. 78201

210-***-**** / 787-***-**** / 787-***-****

E-mail ***********@*****.***

EDUCATION

Universidad del Turabo, Gurabo, PR Graduated on 2013

Degree: MBA in Quality Management

Grade point average 3.54

Universidad Interamericana, Bayamon, PR Graduated on 1998

Degree: BS Biology ; Microbiology

Grade point average 3.67

PROFESSIONAL EXPERIENCE

QA Representative March 2008 – Aug-2013

Lilly del Caribe, Carolina, Puerto Rico

Quality Assurance subject matter expert.

Supervise QA GMP sampling programs for pharmaceutical dry product manufacturing.

Supervise the quality department technical personnel.

Applied statistical tools and standard operation procedures to perform data analysis.

Ensures all work performed is executed in compliance and on time with standard operating

procedures, good manufacturing practices and regulatory agencies (FDA, EMEA, JP)

requirements.

Create, improve and revise SOPs and validation protocols.

Active team member of Lean Six Sigma projects for reducing costs, cycle times, improve

customer satisfaction and enhance quality attributes.

Lead investigator for the quality assurance department. Perform investigations following

root cause analysis techniques, in order to, recommend and implement counter measures

for improvement of quality and avoiding recurrence.

Train personnel new personnel.

QA Technician March 2004 – March 2008

Lilly del Caribe, Carolina, Puerto Rico

Performs water monitoring for purified water system and WFO.

Performs environmental monitoring using the RCS (for viable particles) in clean and

controlled rooms.

Perform compressed air monitoring by membrane filtration method and non-viable particles

testing by Met-One Laser Particle Counter.

Preparation of microbiological trends.

Perform hydrocarbons presence test in the compressed air lines using JC oil indicators.

Microbiologist January 2000 – Jan 2004

Schering Plough, Manati, Puerto Rico

Performed supervisory task as a Senior Analyst.

Verify the inspections of aseptic simulation process for parenteral products.

Strong knowledge of GMP’s, FDA, DEA and USP regulations.

Performed environmental monitoring, such as, Slit To Agar, RCS (for viable particles), Met

One (for non-viable particles), Swabs, Impingers (compressed air) and Rodac s plates of

Pharmaceutical Plant (Aseptic, Controlled and Non Sterile areas) and bulk plants

production facilities.

Double check of the environmental documentation related to Non Sterile areas, bulk plants,

Central Weighing area, and other clean rooms.

Held laboratory GMP and Safety program coordinator positions.

Trained new personnel.

Read a colony count for bacteria and molds.

Preparation of culture media.

SPECIAL SKILLS

I am highly skilled in the use of computers and the Internet, including Microsoft Office

and Internet searches. I learn very quickly, bilingual (English and Spanish), team player, well

organized and results oriented

.

References available upon request.

Contact this candidate