Microbiologist

Janice Villalobos Vélez

Ave. Porvenir # *** Mayagüez, P.R. 00680

787-***-****

**************@*******.***

Summary of Qualification

Professional Microbiologist Analyst with 7 years of experience in Pharmaceutical and Medical Device Company. Knowledge of USP, cGMP, ISO 14000, OSHA and CFR Part 211. Validation execution participation. Company internal lean and environmental audits. Demonstrated experience in microbiology analytical and environmental laboratory tests such as: Endotoxin, Bioburden and Water. Responsible, self started, organized, respectful and flexible. Quality team work oriented with leadership, excellent interpersonal and communication skills. Bilingual.

Accomplishments

 Participated on the development of a quality management system for combination product. The company start-up operation when obtaining final FDA approval within a 12 months period with final profits of 1 billon.

 Team player on implementation of lean manufacturing and 5S in microbiology laboratory with the result of cycle time reduction in different tests.

 Lean Green Belt Training

 LIMS System Administrator

 Biosafety and Ideas Champion

 Participated in continuous improvement activities as Kaizens

 Environmental Monitoring Schedule Planner

Professional Experience

Summer Research Opportunities Program 2001

University of Illinois at Urbana-Champaign

• Performed research project about effects of Pasteurella multocida toxin (PMT) on intracellular signal transduction: cloning and expression of RGS4 protein in E.coli.

Cordis LLC, San Germán, P.R

Microbiologist Analyst 2005 – 2009

 Performed Environmental Monitoring (Airborne Particulate, Airborne Microbes, Surfaces, Compressed Gases, Pressure and Water testing) for controlled areas.

 Plates Inspection and isolated transfers bacteria for ID

 Growth Promotion Test

 Biological Indicators Test (BI’s)

 Bioburden and endotoxin (LAL) product test

 Media Preparation

 Data entry and control charts preparation

 Autoclave Use ( Equipment Sterilization)

 Biosafety Trainer (Blood borne pathogens training)

Cordis, LLC, San Germán, P.R

Manufacturing Operator 2003 – 2005

 Cypher Coated Stents Manufacturing Process ( Spray, Weigh and Visual Inspection)

 Batch Record Reviewer

Jansen Cilag, Latina, Italy

Manufacturing Operator 2002

 Cypher Coated Stents Manufacturing Process Qualification

 Participated in protocols and engineers studies as part of Cypher start-up

Education

University of Puerto Rico, Mayagüez Campus

BS in Industrial Microbiology

23 Chemistry Credits

Interamerican University, San Germán Campus

Teaching Certification

Environmental Sciences Master Program (9 Credits)

Accreditations

 LIMS System Administrator Certification

 Junior- High Sciences Teaching Certification

 Environmental Team (NovaTerra) member

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