Mayra G. Vega Vega, CQA

*** ** *** **. ***.****

Miami, Fl 33132

Mobile: 787-***-****

E-mail: accao7@r.postjobfree.com

CAREER PROFILE

Professional Chemist with broad experience in the Pharmaceutical Industry. Strong experience

in GMP, GLP,and FDA inspections. Experience in pharmacopeia (USP, EP AND JP).

Laboratory Instrumentation background in HPLC, UPLC, GC, UV, FTIR, TOC, Dissolution

baths and automated equipment as MultidoseG3 and TPW. Responsible, self-starter, organized,

respectful and flexible with proven leadership skills. Capable of managing multiple tasks in a

high-pressure environment with minimum supervision. Quality and teamwork oriented with

excellent interpersonal and communication skills. Ability to train others. Computer literate with

knowledge in software’s like: MSOffice, Chromatographic Data System (Chromeleon,

Empower, PeakPro), and Laboratory Information Management System (LIMS). Fully bilingual,

English and Spanish.

PROFESSIONAL EXPERIENCE

NEOLPHARMA, CAGUAS, PR 2013

Laboratory Analyst

Responsible of perform laboratory test, data verification, training other peers and working with

the handling of controlled substances for the Finished laboratory.

MYLAN LLC, CAGUAS, PR 2012

Validation Analyst

Responsible of perform analytical support to process validation, cleaning validation and method

transfer.

PFIZER, VEGA BAJA, PR 2011 – 2012

QC/QO Technical Specialist

Responsible of perform laboratory test and data verification for the Raw Material laboratory

according to the pharmacopeia and the analytical methods.

ASTRAZENECA (FORMERLY IPR PHARMACEUTICALS), CANÓVANAS, PR 2003 – 2011

Analytical Services Validation Analyst

Responsible for lead laboratory project regarding the introduction of new product, validation

process, analytical support to process validation, cleaning validation and monitoring. Write and

review SOPs and Protocols. Responsibilities include travel to international sites, method

transfer, qualification, training, scheduling, troubleshooting, auditing test data of the products for

the support of the FDA approval and manufacturing special duties.

SCHERING PLOUGH, MANATÍ, PR 1997 – 2003

Laboratory Analyst

Responsible for Analytical testing for Raw Material laboratory according to USP and analytical

methods; water systems according USP and EP Pharmacopeia; and analytical support for the

implementation of LIMS in the QC laboratories.

DUPONT-MERCK, MANATÍ, PR 1996 – 1997

Laboratory Analyst

Responsible for perform cleaning validation, including the sampling in the manufacturing area;

and Analytical testing for Stability and Finished laboratories.

WYETH, GUAYAMA, PR 1996

Stability Laboratory Analyst

Responsible for perform Analytical testing for Stability laboratory.

ACHIEVEMENTS

Analytically contributed in the validation of Crestor manufacturing in the Canóvanas site

•

for the American en Europe markets, achieving the FDA approval.

• Successfully contributed with the analysis of the validation of a new product and achieve

the FDA approval.

• Performed a filter equivalence study for the CU and Dissolution tests, achieving a

reduction in expenses.

EDUCATION

Bachelor Degree in Chemistry

UPR – Cayey Campus

Cayey, P.R.

TRAININGS

• HPLC Use, Maintenance and Troubleshooting, Agilent Technologies Inc, Alpharetta,

GA

• UPLC Training, Waters, Caguas, PR

• New Products laboratoty techniques familiarization, Abbott Laboratories, Chicago and

AstraZeneca Pharmaceuticals, Molndal, Sweden

Membership

American Society for Quality

Certified Quality Auditor

Certification number 46060

2

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