Quality Control Analyst

Bonifacio Cuenco

*** **** **., **** *, Upton, MA 01568, United States

*******@*****.*** • Cellular 781-***-****

Summary

I have a bachelor's degree in microbiology and 20 years of quality control experience in the pharmaceutical industry. I

established quality control systems in the Microbiology laboratory. I am experienced with the regulatory requirements

to advance the production of drug products. I have done the research and purchasing of new laboratory equipment

and validated them when necessary. I have coordinated with all departments to fulfill quality control goals. I have

worked the off shift hours to support all departments. I have represented and participated in meetings for quality

control. I have performed routine microbiology laboratory assays.

Experience

Genzyme, Allston, MA October 2012 to Present

Quality Control Analyst

Performing and training on routine microbiological assays like bioburden, LAL gel clot, Gram staining, plate streaking,

environmental monitoring and pipette calibration

Ipsen, Milford, MA November 2008 to October 2011

Quality Control Microbiologist

Established clean compressed air system monitoring, Established microbial identification system, Wrote deviation

reports. Revised and wrote new standard operating procedures, Performed environmental monitoring, Endotoxin

testing, microbial limit, conductivity, TOC, turbidity A550. Established standing orders for supplies

Amylin, Hamilton, OH October 2007 to October 2008

Microbiologist

Performed routine microbiological assays including endotoxin, biological indicator, microbial limit, media performance

and environmental monitoring. Assisted in validation of Isolator and assay. Wrote SOPs and deviation reports.

Baxter, Hayward.CA June 2005 to June 2007

Quality Control Analyst

Performed routine microbiological assays including endotoxin, biological indicator, microbial limit, media performance

and environmental monitoring. Wrote SOPs and deviation reports.

Vaxgen, South San Francisco, CA June 2003 to July 2004

Quality Control Analyst

Performed routine microbiological assays including endotoxin, biological indicator, microbial limit, media performance

and environmental monitoring. Wrote SOPs and deviation reports.

Bayer, Berkeley, CA July 1991 to October 2002

Development Scientist

Assay validation, USP sterility testing, cell culture, mycoplasma, ouchterlony, dialysis, media performance, cell

banking, organism propagation, bactometer sterility, radioimmunoassay, Anti-complement, media performance,

microbial identification, microbial limits, environmental monitoring, Thrombocytopenia, biological indicator, deviation

reports, ordering, procedure writing and revisions.

Education

San Francisco State University, San Francisco, CA 1991

Bachelor, Microbiology

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