Sígsig M

Sígsig M. Jiménez

Los Sauces, Laurel # 107, Humacao, PR 00791

Phone (787) 852-8945 E-mail: eldiaz@caribe.net
Objective

Obtain a position as a Scientist of QA related area where I can apply my strengths and knowledge in total quality systems.

Qualifications Summary

More than 3 years of experience conducting internal quality audits. Provide follow up, corrective and preventive actions to internal quality audits observations, complaints, and product investigations. Organized and goal oriented; ability to work under pressure, with minimum supervision, and in teamwork. Bilingual (English and Spanish) and PC oriented.

Employment History

Alcon, Puerto Rico - Humacao, PR
Internal Quality Auditor 1997 to Present

Prepare and conduct internal audits. Provide follow-up, corrective/preventive actions and effective verification to internal/external audits and product investigations. Prepare FDA products monthly reports and FDA annual product review.

Microbiology Lab Scientist and Environmental Inspector 1993-1996

Conduct analysis of water such as plate count and identification tests. Responsible for conducting environmental inspections at the Ophthalmic Plant.

Packaging Coordinator 1992 to 1993

Supervise Avitine product packaging line.

Schering Plough - Las Piedras

Scientist - Chemical Stability Laboratory. 1992 - 1992 Schering Plough, Las Piedras, PR

Analyze product stability using different methods such as HPLC, GC, and Karl Fisher.

Sígsig M. Jiménez

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Achievements

Promoted to Internal Quality Auditor in recognition of my performance as a scientist.

As Internal Quality Auditor the number of observations in external and corporate audits decrease significantly, other responsibilities such as product investigation reports and complaints were added.

Responsible for preparing the plant for an ISO9002 re-certification with no observations.

Education

Universidad Politécnica de PR
M.S. Engineering Management, with a concentration in Manufacturing

University of Florida, Gainesville, FL
M.S.c. Animal Sciences

Universidad Central de Bayamn
B.S. Biology with a minor in Pre-Medicine

Accreditations and Skills

ISO 9000 Lead Auditor Certification (Perry Johnson Inc.)

Fully acquainted with PC and Windows environments as well as Microsoft Office: Word, Excel, Access and Power Point and Corrective Actions software. Fully knowledge in current GMPs for drugs and medical devices.

Seminars and Courses

How to conduct effective audits with new cGMP.

FDA audits and FDA 483s.

Recent changes and regulations applicable to Quality Laboratories.

FDA requirements for product investigation, complaint management and changes control.

Microsoft Access 2.0 Basic level training (certified).

Microsoft Excel. Intermediate level (certified).