Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Timeline
Generic

Gerardo Rodríguez Vicente

Gurabo

Summary

Licensed Chemist with over thirty years of experience in Quality Control/Quality Assurance and Technical Services conducting method and product validation, method transfer, develop and update procedures and data reviewing in a regulatory environment. Solid analytical and technical knowledge in laboratory analysis, operation, calibration and maintenance of laboratory equipment. Energetic self-starter with experience in planning, organizing, analytical thinking and problem-solving skill to ensure maximum customer satisfaction and business revenue. Prioritize tasks based on available resources to complete objectives. Excellent interpersonal skills, works effectively in a team environment and customer service oriented. Experience in data integrity verification in equipment and equipment software. Execution of assessments, data mapping flow and mitigations for data integrity risk. Experienced in use and Qualification of HPLC (Waters, Agilent, and Shimadzu), UV-VIS, FTIR, Atomic Absorption Analyzer, Gas Chromatographer, Lasentec-FBRM. Computer Software: Empower, Chem Station, Jump, WinLab32, Spectrum, SAP, GMARS, Trackwise, Regulus, Microsoft Word, Excel, and Power Point. Extensive knowledge in cGMPs, GLPs, 21CFR21, local and international industry regulations, Pharmacopoeias such USP, EP, ACS, JP, FDA regulations, operational excellence and EHS regulations. Very good oral and written skills in Spanish and English.

Overview

35
35
years of professional experience
1
1
Certification

Work History

Engineer II, Quality Assurance

Thermo Fisher Scientific, Manati Puerto Rico
01.2022 - 01.2025
  • Work with Manufacturing staff, Technical Services, Subject Matter Experts, and Quality Approvers to determine the scope of the investigations to identify the appropriate root cause to complete the investigation.
  • Participate in generation protocols and review of SOPs.
  • Drive the implementation of effective and appropriate CAPA.
  • Conduct internal audits to maintain Thermo Fisher Manati-Site in compliance with the different regulatory agencies.
  • Follows safety requirements for manufacturing and laboratory working environments.

Data Analyst Investigator

Thermo Fisher Scientific, Manati Puerto Rico
01.2020 - 01.2022
  • Work with Technical Services, Subject Matter Experts, and Quality Approvers to determine the scope of the investigations to identify the appropriate root cause to complete the investigation.
  • Participate in generation protocols and review of SOPs.
  • Drive the implementation of effective and appropriate CAPA.
  • Conduct internal audits to maintain the Quality Control laboratories in compliance with the different regulatory agencies.
  • Present and defend investigations during regulatory inspections.
  • Follows safety requirements for laboratory working environments.

Computer System Validation Specialist

BD/QCCS, Humacao Puerto Rico
01.2019 - 01.2020
  • Review and validate Computer System applications. Generate the necessary documentation for the systems in compliance with 21 CFR Part 11 and GxP FDA Regulations and QSR 820.
  • Performs audits on computer systems at manufacturing and laboratory areas to ensure data integrity.
  • Worked with mitigations to correct the data integrity risk found during the data integrity assessments.
  • Audit trail verification on the validated computer system at manufacturing and quality groups.
  • Followed Computer Systems Validation CSV Master Plan to author, review and approve CSV.
  • Co-ordinated with the vendors in commissioning of the instruments upgrade software, implement new systems or maintenance of systems, and resolving technical issues.
  • Reviewed and followed SOPs to help the business process in line with FDA regulations.

Technical Support Chemist

Eli Lilly del Caribe, Carolina Puerto Rico
01.2010 - 01.2018
  • Oversee multiple projects across all phases of development.
  • Monitor workflow and make timeline adjustments as needed.
  • Perform thermal mapping qualification activities by using data loggers and Kaye Validator. Experience in the development and execution of the thermal mapping activity protocols.
  • In charge of project group working with new equipment installation and qualification.
  • Assessment of analytical instrumentation for data integrity compliance.
  • Documentation review of the existing computerized equipment to ensure that they meet the ALCOA criteria
  • Review and validate Computer System applications. Generate the necessary documentation for the systems in compliance with 21 CFR Part 11 and GxP FDA Regulations and QSR 820.
  • Abundant experience in generating and reviewing Computer Systems CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the pharmaceutical industries.
  • Qualify and validate laboratory instrumentation by developing a certification plan like design, installation, operational and performance qualifications.
  • Perform initial & periodical qualification: spectrometer, moisture analyzers.
  • Approve analytical test of cleaning assay, raw material and final product to assure the quality results from the laboratory.
  • Support to team leader in task distribution to assure the maintenance and organization of Validations Quality Control laboratories.
  • Assist the Quality area during internal and external agency audits.
  • Generate control charts of results trends to initiate an analytical investigation and come to conclusions according to the investigation.
  • Validate and transfer analytical methods according to regulatory regulations and compendia standards.
  • Support the generation of protocols. Design and evaluate laboratory models and methods.
  • Train the new analyst in equipment operation and responsibility task.
  • Support the investigations to define cause and possible effects.

Process Development Laboratory, MS&T Representative

Eli Lilly del Caribe, Carolina Puerto Rico
01.2004 - 01.2010
  • Support the analytical components of MS&T laboratory operations by maintaining of the in-process method, operation, and implementation of a variety of final bulk methods for in-process intermediate characterization, Non-Conformance events solving and model development.
  • Develop and Qualify Laboratory model for technical support in model development, process troubleshooting, process optimization projects and cost reduction alternative.
  • Execute technical validation, direct protocol documentation and procedure assistance at Biotechnological plant start-up.
  • Apply design of experiment methodology and statistical tools for the execution of laboratory studies and the interpretation of data.
  • Assist the protein manufacturing process by providing effective solutions and direct assistance to technical issues and Non-Conformance event investigation.
  • Works in a specific scientific area, such as process validation, cleaning validation, continuous process verification, and manufacturing technical support.
  • Train TS/MS Representative on the use of laboratory models and analytical techniques.

Process Scientist II/Process Scientist I

Bristol-Myers Squibb Company, Humacao, Puerto Rico
01.1999 - 01.2004
  • Provide support of current manufacture products including API’s and intermediates.
  • Perform technical transfer of all and new products to the manufacturing plant.
  • Perform successful transfer of new technology for the laboratory and production areas.
  • Conducted laboratory and plant trial for the modification of current reactions and crystallization processes and new vendor material characterization.
  • Evaluate process deviations and improvements.
  • Participate in the use of new technology for impurities identification.
  • Collaborate in technical transfer activities of API’s.
  • Perform process analytical technology (PAT) feasibility studies of Mid-IR and Particle Size Process Monitoring (Lasentec-FBRM).
  • Supervise employees from different fields related to science like bachelor, master degree students and science teachers.
  • Evaluates and contributes to the design of manufacturing processes and supports problem-solving as necessary.

Analytical Method Development Chemist

01.1997 - 01.1999
  • Developed and validated new analytical methodology for cleaning validation.
  • Responsible for the development and validation for new analytical method to support the manufacturing activities.
  • Developed and validated new analytical method for detection of new impurity for a new raw material vendor.
  • In charge of the laboratory PM and Calibration program.
  • Conduct laboratory investigation, review of laboratory-test and review of SOP’s.
  • Required the management of service agreements, purchase orders and inventory controls of material.

Laboratory Analyst

01.1990 - 01.1997
  • Execute sample analysis of raw materials, in-process and finished products and cleaning samples according to the specifications.
  • Performed analytical test to all manufactured goods using CGMP’s, SOP’s, FDA and US Pharmacopeias regulations and guidelines.
  • Document results in a neat, accurate and complete manner.

Education

BS Degree in Science - Chemistry

State University of New York/Stony Brook

Skills

  • Critical thinking
  • Quality control
  • Technical writing
  • Project planning
  • Data analysis
  • Failure analysis

Accomplishments

  • RED Award-Teamwork 2013
  • RED Award-Teamwork 2014
  • RED Award-Support Startup for new production process 2015
  • Achievement Award-Teamwork 2010
  • Award due contributions to EHS 2002
  • Impact Award due to performance evaluation in 2003
  • Excellence Award due to performance evaluation in 2004

Certification

  • Licensed Chemist #3795
  • HPLC and GC troubleshooting certification
  • Audit and investigation trainings
  • Safety certifications: DTOP, RCRA, OSHA

Languages

Spanish
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)

Timeline

Engineer II, Quality Assurance

Thermo Fisher Scientific, Manati Puerto Rico
01.2022 - 01.2025

Data Analyst Investigator

Thermo Fisher Scientific, Manati Puerto Rico
01.2020 - 01.2022

Computer System Validation Specialist

BD/QCCS, Humacao Puerto Rico
01.2019 - 01.2020

Technical Support Chemist

Eli Lilly del Caribe, Carolina Puerto Rico
01.2010 - 01.2018

Process Development Laboratory, MS&T Representative

Eli Lilly del Caribe, Carolina Puerto Rico
01.2004 - 01.2010

Process Scientist II/Process Scientist I

Bristol-Myers Squibb Company, Humacao, Puerto Rico
01.1999 - 01.2004

Analytical Method Development Chemist

01.1997 - 01.1999

Laboratory Analyst

01.1990 - 01.1997

BS Degree in Science - Chemistry

State University of New York/Stony Brook

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Gerardo Rodríguez Vicente