Look for a challenging position within the pharmaceutical and manufacturing industry in which
I can contribute into the performance of the company with my knowledge acquired during my work
experience.
Skills
Knowledge in Microsoft Office.
Knowledge of EMPOWER System (1,2, and 3).
Knowledge of LIMS Systems (Labware LIMS, Sample Manager and Sample Manager 2004R2).
Knowledge of cGMP's, Good Laboratories and Documentation Practices.
USP Pharmacopeia littered.
Work History
QC Technician, 01/2009 to Current Apex Systems – Southfield, MI,
Performed Raw Material, Finish and Stability product analysis for oral solid dosage product (Tablets) (Assay, CU, Dissolution, ID, Impurity test) following analytical methods and USP Pharmacopeia.
Performed testing following analytical techniques such as HPLC, UPLC, Dissolution Baths, UV-VIS, IR, pH meter,TLC, Conductivity, and Wet Chemistry.
Documented and Reviewed raw data to ensure testing was performed accurately and in compliance with GLP, GMP, USP, SOPs and applicable guidelines.
Executed Validation and Method Transfer of new products.
Executed investigational plans and protocols to support the investigation process.
Executed Cleaning Validation protocols by sampling and analyzing the samples.
Performed laboratory EHS audits as a member of the laboratory safety team.
Maintained good laboratory housekeeping following the 5s and kaizen iniciatives.
Performed basic troubleshooting to instruments when needed.
Trained and qualified my colleagues in the techniques in which I was qualified since I was an approved trainer.
Supported as a member of the Quality Pillar in the Zero Defects Initiative launch.
QC Associate QOTT, 09/2008 to 11/2008 Wyeth Pharmaceuticals – City, STATE,
Performed stability and finish product analysis for parenteral product (Assay, pH, Description).
Executed Validation protocols at the different stages of the manufacturing process.
QC analyst and LIMS Documentation Technician, 03/2008 to 09/2008 BRISTOL MYERS SQUIBB – City, STATE,
Performed stability and finish product analysis for oral solid dosage product (Tablets and Capsules) (ID by IR, GC analysis, Description).
Supported the implementation of the new chromatographic acquisition data system (EMPOWER 2) in the laboratory.
Created static data and supported as part of the implementation team of the new Laboratory Information Management System (LIMS) Sample Manager 2004R2.
QC Associate QOTT, 02/2007 to 03/2008 Wyeth Pharmaceuticals – City, STATE,
Performed stability and finish product analysis for parenteral product (Assay, pH, Description).
Executed Validation protocols at the different stages of the manufacturing process.
Coordinated activities to implement the 5's initiative philosophy in the laboratory.
Initiated the Change Control process for the equipment installation and qualification in the new facilities of the QC laboratory.
Associate QC Specialist, 04/2006 to 02/2007 Wyeth Pharmaceuticals – City, STATE,
Performed stability and finish product analysis for oral solid dosage product (Tablets) (Description, Friability, Disintegration, Dissolution, Degradation and Impurity test, TLC, Assay, ID by Melting Point).
Education
Certified Pharmacy Technician: , Expected in 2012 Inter American University - Bayamón, PR GPA:
B.S in Science: Chemistry, Expected in 2006 Inter American University - San Juan, PR GPA: Science Chemistry
High school Graduate: , Expected in 1999 Academia Santo Tomas de Aquino - Bayamón, PR GPA:
Certifications
HPLC Certified by the Chromatography Institute of America
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