Chemist/ Validation Specialist
Resume:
Curriculum Vitae
María I. Rodríguez Dones
Box *06 Cidra, Puerto Rico 00739
Professional Profile and Objective
I am a Chemist with experience within the pharmaceutical, beverages, medical device and healthcare industries. My major experiences have been as a Quality Control Chemist and Laboratory Validation Specialist. As part of my experiences, I was award for my achievements in leadership, team work and decision making to deliver site validation commitments within quality standards and on time. My responsible work ended in excellent performance evaluations.
I had worked with chromatographic data systems as well as with data and workflow systems such as SAP, TrackWise, Empower, PeakPro, LIMS and others. I had experience training and mentoring others, work with time management and prioritization skills, fluent in English and Spanish in both oral and written. Trained in Process Validation.
I considered myself as respectful, honest and responsible, with problem solving skills and have the ability to manage multiple tasks. I am always open to education and constructive critics and able to work under minimal supervision. I am always committing to pursue the goals established.
My goal is to find a challenging position within the sales, biotechnology and pharmaceutical or validation and research areas where I can contribute with the knowledge acquired during these years and acquire more experience in order to grow as a science professional and as a valuable citizen.
Work Experience
GlaxoSmithKline, Cidra PR
December 2005 to February 2008
Laboratory Validation Specialist, Metrology Area
Within this position I participated as author, technical reviewer and / or executioner of laboratory equipment validation deliverables for equipments that includes dissolution baths, Caliper Multidose G3, Phoenix 8000 TOC, Glassware Washers, incubators, autoclaves and others. I authored and performed technical review of standard operating procedures for the calibration and use for a variety of laboratory equipment and systems, in addition to the Laboratory Systems Validation Procedure and collaborating with improvements made to the site global validation procedure.
Responsible for evaluation and approval of executed Work Orders related to technical problems, laboratory investigations, calibration, PM’s and/or troubleshooting of all laboratory equipment delivering all equipments on time to be used by the laboratories analysts. Plan and coordinate the daily, weekly and monthly Metrology Technicians work schedules. I delivered validation plans and schedules to site leadership and work as part of the site validation team as QC Labs representative, in order to improve validation strategies and lower costs.
GlaxoSmithKline, Cidra PR
August 2002 to December 2005
Laboratory Analyst
As a Laboratory Analyst my responsibilities were the analysis of solid, liquid drug products and stability samples by tests like dissolution, Content Uniformity, degradation, assay and TLC. The documentation and analysis of data were part of the jobs assigned. Preparation of sample by means of dilutions and weighing or as specified on the testing procedure or pharmacopeias monographs. As part of my tasks assigned was the review and correction of laboratory logbooks. As an achievement within this position, I design and prepared solution labels, logbooks and seals to improve the laboratory performance and compliance with GLP’s. Perform calibration and trouble shooting of the equipments used for testing.
JanssenOrtho LLC Gurabo, PR
November 2001- June 2002
QC Chemist
Responsibilities encompass the analysis of Raw Materials and water by means of test like titrations, ID, LOD, Heavy metals, fusion point determination and other USP, EP and JP tests as specified in the test procedure. Documentation and interpretation of data acquired.
Ivax Pharmaceuticals Cidra, PR
January 2000-August 2001
QC Chemist
I performed analysis to finished products including controlled samples, Raw materials, validation, stability and in-process samples by chromatography, TLC, Heavy Metals and Dissolution tests in addition to documentation and interpretation of the data acquired.
PepsiCo Puerto Rico Inc Cidra, PR
January 1999- January 2000
QC Chemist
My responsibilities were the analysis of raw materials, in- process and stability samples. Participate on sensory evaluation panels. Improve laboratory safety awareness and the disposal of hazardous materials procedure.
Comunidad Geriátrica Ciudad Sabanera, Cidra PR
1995 – 1999
Geriatric Technician, Part Time
My responsibility was to assists the elderly people on their daily basis. Manage physicians’ appointments and services.
Education
University of Puerto Rico Cayey, PR
Bachelor’s of Science Degree in Chemistry
During the undergraduate period I performed research in Physical Chemistry with Dr. Juan Estevez, published and presented papers on ACS congresses. Also, I work as part of my curriculum at Baxter Healthcare at the Raw Material Laboratory.
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