Summary of Qualifications

Quality Control professional with solid experience in handling and using aseptic techniques, microbial selection, culture media preparation, biohazard material handling and solution preparation. Hands-on working with laboratory instruments such as: analytical balances, pH meters, Oxygen analyzer, micropipettes, bacteriological safety cabinets, instrument calibration and troubleshooting techniques among others. Knowledgeable in blood borne pathogens, 6S practices, corrective and preventive action analysis, out of specification, environmental monitoring, data analysis, reporting and final product UD disposition in SAP system. Able to maintain laboratory supplies and equipment in compliance with FDA Regulations, OSHA Regulations, ISO Regulations (ISO 9001, 14001, 13485), cGMP's and SOP's. Professional with excellent communication, leadership and interpersonal skills. Bilingual in English and Spanish.

Professional Experience

Becton Dickinson, LTD, Cayey, PR 2013-present

Quality Control Technician

Perform tests to batches received at the Quality Stability lab and Final Media lab and document results accordingly

Coordinate routine microbiology and physical tests of samples supporting finished product, Validations (PQ, PQ/PV, OQ, ES, and CC), Stability and Customer Complaint

Worked with Gram Staining, Starting voltage, pH, Vacuum draw, Oxygen percentage analysis, Microbiological Growth Performance and Microbiological Growth Performance with Antibiotics

Report OOS immediately to Supervisor, opened investigations for root cause analysis and performed corrective / preventive actions

Report all results on SAP and Storm Program (Stability Bank Data)

Complaint / Stability Leader and Laboratory Assistant

Received and identified samples that were requested to be in the Stability Program

Kept contact with Research and Development Facilities to exchange results of tests

Schedule test points and generated Stability Summary Reports as part of the Stability Protocol

Shipped samples to Research and Development facilities for further testing

Customer Complaints

Tested Returned Goods or Reserve samples per Defect described in the Complaint report

Report results, close investigations and deliver results to QA Department for evaluation

Patheon Inc., Caguas,PR June 2012-February 2013

Manufacturing Operator

Trained to document and perform duties in Coating Solution, Weighing and Compression.

Education

BS- Biology

Interamerican University of Puerto Rico, Barranquitas Campus

Graduated 2011