Dulce María Rivera Rosario

Magdalena Arce Miranda

PO Box 3280 – Juncos, Puerto Rico 00777 – Tel. 787-734-7426 or 460-3978

Objective

To apply my background in Industrial Engineering in a challenging and career oriented position in the areas of Manufacturing or Services

Background Summary

Self-Starter Industrial Engineer with ten (10) years of experience in the Pharmaceutical Manufacturing environment as a Production Supervisor and Quality Engineer. Work very well under pressure and with minimum supervision. Have experience in supervisory and manpower planning. Excellent knowledge of aseptic measures for the manufacturing of sterile drugs and medical devices. Exposure to statistical techniques and experience in financial aspects of manufacturing. Have experience developing SOPs and in investigating customer complaints. Knowledge and compliance in GMPs, FDA, DEA, ISO 9002 and OSHA Regulations. Computer literate in Microsoft Office and experience with AS/400 Computer System. Good verbal and written communications skills both in English and Spanish.

Professional Experience

Alcon Puerto Rico, Inc. - Humacao, Puerto Rico 1990 - Present

Quality Engineer 1998 - Present

Manage the Process Scrap Program in an effort to improve manufacturing processes utilizing statistical analysis. This includes preparing monthly reports on scrap, downtime, set-up, and material usage analysis as well as developing and maintaining SOPs. Perform customer complaint evaluation and recommend disposition.

Industrial Engineer – Independent Contractor 1997 - 1998

Develop, improve, and update Labor Standards and MBRs for Ophthalmic Sterile Products and Viscoelastic products. Performed as a Production Supervisor for a three-month period.

Production Supervisor 1990 - 1997

Supervise Compounding, Filling, and Packaging groups in the manufacturing of sterile solutions/suspensions, and Filling/Packaging of Medical Devices, tablets, nasal drops and suppositories.

Magdalena Arce Miranda

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Major Accomplishments

Developed, updated, and implemented labor standards for sterile drugs. Designed forms and tables to improve process revision.

Trained and implemented sanitizers filtration to minimize the contamination possibility in aseptic areas.

Analyzed in-process data and included cost analysis to improve trend information for scrap reports.

Developed and improved MBRs for sterile drugs to standardize manufacturing instructions.

Participated as a team member in a capacity study to improve the product yield.

Participated in the ISO9002 certification as part of the manufacturing team.

Performed as Plant Manager during his absence with excellent results and verbal recognition on his part.

Education

University of Puerto Rico - Mayaguez Campus
Bachelor of Science in Industrial Engineering

Engineering in Training (EIT) Certificate

Training

Basic Industrial Course in Preparation of Parenteral Products

ISO 9002

First Aid and Cardio Pulmonary Resuscitation (CPR)

Hazardous Waste Operations and Emergency Response

Hazard Risk Assessments for Personal Protective Equipment

The Supervisor and the Application of Labor Laws

Integrity Testing Certification Course

Basic Principles in the Preparation of Sterile Dosage Forms