Project Manager Quality Assurance
Resume:
To Whom It May Concern:
I hold a bachelors degree in science with a major in Chemistry and a
minor in Computer Programming from the Pontifical Catholic University of
Puerto Rico in Ponce. Since my graduation in 1986, I have worked
primarily within the pharmaceutical industry from different perspectives.
At MOVA Pharmaceuticals work as Validation Manager responsible for
Computer System Validations and Laboratory equipment qualifications at
all sites in Puerto Rico.
I worked for the Food & Drug Administration for nine years as Senior Drug
Chemist, Investigator and Computer Specialist. Team Leader for the
NDA/ANDA Laboratory group while assign to the Southeast Regional
Laboratory. Work in the San Juan District Office for five years. I
performed NDA/ANDA/IND pre-approval inspections nationwide and in foreign
countries as part of the FDA Foreign Inspection program.
I have ample experience using and auditing LIMS systems. Serve as a
Computer Expert for the Assistant US Attorney, Baltimore Office in grand
jury cases regarding violations to the Food, Drug and Cosmetic Act. For
which, I conducted witness interviews, system computer searches, etc.
I have been related to the StarLIMS Company for approximately 10 years,
as user, administrator and project manager. In 2003, I became a Special
Assistant to the Executive Director of the Instituto de Ciencias
Forenses, responsible for information systems. StarLIMS was the main
information system used on the institute operations, installed on the
main offices on San Juan and three regional laboratories (Arecibo,
Mayag ez, and Ponce) and an investigation resident post on Ponce. Until
February 2007, I was responsible for all programming changes to the
application and its validation/verification, for which I received
training from StarLIMS engineers. I created new applications and
modified existing ones in order to adapt to changes in operation within
the institute.
During this time, I travel to provide presentations on the StarLIMS
forensic application, such as at the users meetings and the17th Meeting
of the International Association of Forensic Sciences (IAFS) August 2005,
in Hong Kong and the Puerto Rico Chemists Conferences.
From March 2007 to November 2008, I worked as a consultant and QA Manager
for StarLIMS on project management of new implementations. I worked on
the Jamaica Public Health Laboratory LIMS implementation and the Puerto
Rico Health Department LIMS implementation. The Jamaica project was
completed on September 2008, and the PR project is still ongoing. During
this time, I performed system installation and application setup; provide
training sessions, worked on solving infrastructure problems, and serve
as liaison between developers/engineers and project administrators. As
QA Manager was responsible to review and approve all documentation
generated for new applications or modules on the Hollywood, FL site.
Audit Florida operations to compliance to ISO 9001 standards.
Since March 2007, I have been working as Consultant in the areas of
regulatory compliance, validation, qualification, third party audits,
training, and regulatory auditor. Support to informatics projects as
project manager and support for installation of LAN infrastructures.
Work as a third party auditor performing audits to assess compliance with
laws and regulations of the US FDA on drug, dietary supplements and food
manufacturers.
I am looking forward to discuss my experience and skills to fulfill your
needs.
Cordially yours,
Jose H. Lebron
R SUM
Jose H. Lebron
I-30 Luis Mu oz Mar n Avenue * Villa Carmen
Caguas, Puerto Rico 00725
Mobile: 787-***-****
Education
Pontifical Catholic University of Puerto Rico
Ponce, Puerto Rico
Bachelor in Science
Majoring in Chemistry
May 1986
Puerto Rico Chemist License: #3455
Work Experience
March 2007 - Present Senior Consultant
I/O Services
Work in the areas of regulatory compliance, validation, qualification,
third party audits nationally and internationally, training, and
regulatory auditor. Support to informatics projects as project
manager and support for installation of LAN infrastructures. Work as
a third party auditor performing audits to assess compliance with laws
and regulations of the US FDA on drug, dietary supplements and food
manufacturers. Worked as project manager and QA Manager for StarLIMS
on support on new implementations.
September 2003 - February 2007 Chief Information Officer
Forensic Science Institute of PR, San Juan,
Puerto Rico
I was responsible for the operations of the Data Management Center,
StarLIMS system and all automation areas within the operation of the
institute. My responsibilities include the design and implementation
of automated systems for the Human Resources and Auxiliary Services
departments. Directly supervise all employees within the Data
Management Center.
May 2002 - August 2003 Senior Validation Consultant
Validation Consultant Services, Caguas, Puerto
Rico
Work in the areas of regulatory compliance, validation, qualification,
third party audits, training, and regulatory auditor.
February 2001 - May 2002 Validation Manager
MOVA Pharmaceutical, Caguas, Puerto Rico
My department was responsible for the development and execution of
qualifications or validations for automated systems and laboratory
equipment's. Was responsible for content review and approval for
protocols/reports, service change controls, and standard operating
procedures within the department. Responsible for the regulatory
compliance of all automated systems, such as: LIMS, PRISM MRP II, SAP,
CFR Part 11 - Electronic Records/Electronic Signatures, etc. My
responsibility included MOVA Pharmaceutical manufacturing sites in
Puerto Rico: Caguas, Carolina and Manat .
May 98 - February 2001 Compliance Assurer (QA Manager)
Pfizer - (Searle), Caguas, Puerto Rico
Responsible for the evaluation and regulatory decisions as they
pertain to a self-directed process team (B), Engineering, Laboratory,
and Information Technology. Reviewed and approved protocols and
reports, product master formulas and specification change controls,
validation change controls, standard operating procedures, material
review dispositions, process or procedure deviations, process
validations, and equipment qualifications. Responsible for the
regulatory compliance of automated systems, such as: LIMS, PRISM MRP
II, SAP, etc. Had supervisory responsibility of Compliance Analysts
responsible for product record review and disposition.
R sum Jos H. Lebr n - Page 2
July 90 - April 98 Chemist/Computer Specialist/Investigator
US Food & Drug Administration
San Juan District Office & Southeast Regional
Office, Atlanta, GA
I served as Acting Supervisory Chemists and was the Team Leader for
the NDA/ANDA Laboratory group in the Regional Laboratory. The NDA/ANDA
group responsibilities were method validations, method verifications,
chromatography, computers, and laboratory inspections. I worked as
investigator for NDA/ANDA Pre & Post approval inspections domestically
and in the foreign inspection program of the International and
Technical Operations branch. I was one of the investigators trained
to perform computer system validation's audits. Represented the agency
in scientific meetings, where I gave presentations in a variety of
topics, such as: method validations, stability testing, computer
validations/inspections, cGMP's & cGLP's inspections, regulatory
compliance, etc. I served as the computer expert for the US Assistant
District Attorney in the Baltimore for FDA cases. I was responsible
for the ADP/IRM training concerning computer applications,
validations/auditing within the Southeast Region. I designed computer
applications used in the regional office and nationwide. I served a
six months detail as the Director of the Management and Program
Support Branch.
March 90 - July 90 Chemist
Smith Kline & Beecham (Glaxo Smith Kline),
Cidra, Puerto Rico
I was assigned to the dissolution area in the Quality Assurance
department were I performed dissolution and potency analyzes to drug
products and stability samples. I designed computer programs for the
calculation and reporting of analyzes within my area, using the raw
data gathered from various analytical instruments.
September 88 - February 90 Chemist
Ayerst Wyeth Pharmaceutical, Guayama, Puerto
Rico
I performed full analytical testing to drug products and stability
samples. I performed methods and process validations on new products
and formulations. I maintained analytical instruments and performed
instrument operational qualifications and wrote Standard Operational
Procedures. Also, review analyst worksheets for approval.
Concurrently, I modified existing computer applications in FORTRAN
computer language when requested in the CALS system. Performed data
archiving sessions and execute the weekly system backups.
March 87 - August 88 Chemist
US Food & Drug Administration
Northeast Regional Laboratory, Brooklyn, New
York
I worked performing drug analysis to assure compliance with the law
and firm specifications. I analyzed raw materials as well as finished
drug products. Also, I received training in the areas of food
chemistry, pesticide analysis, filth etc. I used HPLC's, GC's, UV/Vis
spectrophotometer and other analytical instruments.
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