Magdalena Arce
Miranda
To
apply my background in Industrial Engineering in a challenging and career
oriented position in the areas of Manufacturing or Services
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.
Alcon Puerto Rico, Inc. - Humacao, Puerto Rico 1990
- 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
Page Two
v Developed, updated, and implemented labor standards for
sterile drugs. Designed forms and
tables to improve process revision.
v Trained and implemented sanitizers filtration to minimize
the contamination possibility in aseptic areas.
v Analyzed in-process data and included cost analysis to
improve trend information for scrap reports.
v Developed and improved MBRs for sterile drugs to standardize
manufacturing instructions.
v Participated as a team member in a capacity study to improve
the product yield.
v Participated in the ISO9002 certification as part of the
manufacturing team.
v Performed as Plant Manager during his absence with excellent
results and verbal recognition on his part.
Engineering
in Training (EIT) Certificate
Training
v Basic Industrial Course in Preparation of Parenteral
Products
v ISO 9002
v First Aid and Cardio Pulmonary Resuscitation (CPR)
v Hazardous Waste Operations and Emergency Response
v Hazard Risk Assessments for Personal Protective Equipment
v The Supervisor and the Application of Labor Laws
v Integrity Testing Certification Course
v Basic Principles in the Preparation of Sterile Dosage Forms