MARCIA DEL ROCÍO BALAGUERA GELVES
Mayagüez
Summary
Professional scientist with significant experience in laboratory chemical analysis and research. Skilled in various analytical techniques, including chromatography and spectroscopy, with strong foundation in laboratory safety and regulatory compliance. Known for collaborative approach, problem-solving skills, and adaptability to changing project requirements. Proven track record in delivering accurate results and contributing to team success. Due to the interdisciplinary nature of my Ph. D dissertation, I have earned experience in Materials Sciences, Biochemistry, as well as Analytical and Organic Chemistry, methodically handled delicate materials executing appropriate testing, sampling, and reporting as a Complaint Analyst in addition to analytical testing as an associate and as staff Scientist for the Technologies industry. After serving as a Technical Services Specialist for Pfizer, I am proficient in R&D of manufacturing processes with Active Pharmaceuticals in the Pharmaceutical and Biotechnology industries. Reviewed process validation and conducted investigations (QAR) and implementation of appropriate corrective actions (CAPAs), Ensured investigations of plant events are completed thoroughly and documented accurately to be included in the plant CAPA system, using five whys analysis, or investigating, quality improvement, and critical thinking, with different strategies and procedures, like Root Cause Analysis. It is frequently connected with Lean Manufacturing, where it is utilized to recognize and kill inefficient practices. Additionally, it is used in the examination period of the Six Sigma quality improvement technique. Optimize the production processes to increase yield/quality, reduce variability and reduce manufacturing costs of both new and existing processes. Also used Fishbone Analysis, which offers several benefits for accident research. It promotes a structured approach, involving multifunctional teams, to uncover the root causes. On the other hand, performance impact analysis and corrective and preventive action for events, leading and participating in quality improvement programs, and assurance of cGMP. Determination of the need for non-routine reprocessing documentation and evaluation of action protocols, while maximizing the production processes to increase yield/quality, reduce variability and reduce manufacturing costs of both new and existing processes. On the other hand, performed evaluation of Materials characterization and analysis: e.g. RAMAN (SERS), XRD, FT-IR, SEM, pH, conductivity, TOC, AFM, Fluorescence, UV Visible Spectroscopy, chromatography (GC, HPLC). Experience working with cross-functional and research. Experience working with cross-functional and research teams. Adaptable ability to communicate with individuals at all levels of expertise.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Laboratory Chemist
GENERAPR
07.2023 - 06.2025
- I have worked supervising laboratory technical staff and instrumentation technicians.
- I coordinated and evaluated complex activities to produce demineralized water, verifying compliance with all parameters in wastewater treatment analysis, pH, conductivity, Total organic carbon, inorganic compounds, Volatiles compounds (VOCs), chemical testing of purified water used in power generating units, and evaluating results in the chemical laboratory.
- I also supervised the cleaning and maintenance of the Reverse Osmosis System and the Electrodeionization System.
- I also made purchases and maintained an updated inventory for the laboratory and the demineralized water plant.
- I prepared monthly, semi-annual, and annual reports on wastewater discharged to the Puerto Rico Water and Sewer Systems, as well as on the handling of explosive substances reported to the Puerto Rico Police.
- I evaluated statistical data as needed (e.g., water analysis, etc.).
- Ensured that quality parameters for demineralized water and wastewater treatment comply with government agencies and the Environmental Protection Agency.
- Managed two technical service staff members, collecting work reports, and overseeing tasks.
- Evaluated new equipment and technologies for potential integration into laboratory operations.
- Collaborated with cross-functional teams to optimize research projects, resulting in more effective problem-solving approaches.
- Maintained a safe working environment through strict adherence to safety protocols and proper hazardous waste disposal practices.
- Contributed to successful audits by maintaining comprehensive documentation of laboratory activities and complying with regulatory requirements.
- Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records and work instructions.
- Assisted with collecting, identifying and packaging hazardous and non-hazardous waste products to comply with Resource Conservation and Recovery Act regulations.
- Prepared waste drums for pick-up and delivery to comply with local, state and federal regulations for treatment and disposal of hazardous waste.
Chemist, Shift Supervisor
Puerto Rico Electric Power authority
06.2020 - 06.2023
- Supervision, Coordination and evaluates activities complex for produces demineralized water, verifying wastewater treatment, analysis, chemical testing, and evaluation of results in the chemical laboratory of an Electric Power Generatrix, during a work shift.
- Provides technical support to the chemistry laboratory personnel to production of deionized water from a demineralized water plant.
- Performs chemistry laboratory schedule and tests to High Purity water to avoid delay in the release of the product, assuring quality and safety work, and reports to middle or upper management with any ongoing issues or problems.
- Makes the purchase and all materials required in the laboratory and desmineralized water plant, prepare working orders, shopping and services, quotes, specifications, technical evaluations using computer programs.
- Maintains controls over inventories of equipment and materials on a timely basis to assure efficient development and maintain validation in all protocols for various controls and activities of an Electric Power Generatrix.
- Solve difficult technical problems, devise solutions.
- Participate in laboratory certification preparation and renewal.
- Maintains a clean lab.
- Perform shift work which includes all day, afternoon, night, weekend, and holiday assignments.
- Verify the wear personal protective equipment (PPE), in the workers.
- Provide on the job training.
- Supervise and operate, maintain, calibrate, and troubleshoot analytical/miscellaneous instrumentation.
- Prepares monthly, quarterly, and annual reports for the wastewater discharged to the Puerto Rico Aqueducts and Sewers Authority.
- Performs statistical data evaluation as needed (e.g., Water Analysis, etc.).
- Wastewater quality parameters for the Treatment of Demineralized Water and Wastewater comply with the Government Agency and the Environmental Protection Agency.
- Managed multiple projects simultaneously, ensuring timely completion within budget constraints while maintaining high-quality output standards.
- Modified and adapted standard methods and procedures to solve analytical problems.
- Reduced waste and improved resource utilization by implementing green chemistry principles in product development.
- Trained and mentored new staff on operational procedures and best practices.
- Maintained clean and well-organized production areas to avoid violations or unnecessary work delays due to hazards or inefficient layouts.
- Managed shift operations, supplied resources and monitored team performance to keep business profitable and running smoothly.
External/Internal Complaint Analyst
Fresenius Kabi
07.2019 - 10.2019
- I was responsible executing and controlling the following product complaint directives: Received and documented complaint samples as required.
- Evaluate all complaint samples and perform the required testing evaluated used complaint samples in the Biohazard laboratory at San German plant as required.
- Document all product evaluations.
- Input evaluated complaint data into the Complaints System.
- Prepared Monthly, reports as required.
- Reviewed the current manufacturing process to identify sources for defects as found during the product evaluation.
- Visit blood centers, performed batch records review, evaluate retention sample as required.
- Participated in and supported Environmental, Safety, and Health to meet organizational goals.
- Made product quality decisions when required.
- Provided support to the Manufacturing and Quality departments in their goal to eliminate customer complaint issues.
- Participated in the internal assessment of assigned areas or systems.
- Generated and approved all necessary documentation related to product quality.
- Provided support in monitoring product and process performance.
- Participate and support Environmental, Safety and Health to meet organizational goals.
- Make product quality decisions when required.
- Prepare reports and other forms of feedback on quality issues.
- Support process improvement projects.
- Participate in 'Quality Management.
- Analyzed customer complaints to identify trends and root causes, enhancing product quality and customer satisfaction.
- Worked closely with cross-functional teams to address product or service concerns raised by customers.
- Investigated and resolved customer inquiries and complaints quickly.
Scientist
RCM Technologies, Inc/Thermofisher
09.2018 - 07.2019
- Routinely conducted analytical commercial pharmaceutical area and analytical testing such as: (Assay, Content uniformity, raw material).
- Audited raw data results to the laboratory documentation.
- In addition, directly involved in management and receiving of reagents and Standards inventory.
- Implemented quality control measures to ensure the accuracy and reliability of experimental results.
- Followed strict safety protocols, protecting staff and assets while carrying out technical procedures and research protocols.
Laboratory Instructor of Organic Chemistry
Universidad de Puerto Rico at Humacao
08.2015 - 05.2017
- Main Duties: Laboratory Instructor of Organic Chemistry for undergraduate students.
- Facilitated hands-on training in laboratory techniques and safety protocols for undergraduate students.
- Developed and implemented laboratory exercises to enhance student understanding of scientific concepts.
- Conducted workshops on advanced laboratory equipment, promoting proficiency in innovative scientific methods and technologies.
- Evaluated student performance through assessments, testing and writing evaluations, providing constructive feedback to promote growth and improvement.
- Collaborated with fellow instructors to share resources, ideas, and strategies for improved student outcomes.
- Demonstrated skills and safety procedures to students during laboratory sessions.
- Worked with program director to develop and implement successful lesson plans.
- Evaluated and supervised student activities and performance levels to provide reports on academic progress.
- Participated in various campus memberships at each assigned school to promote academics and faculty development.
CW-GMP03 Associate Scientist/ Process Development
Amgen
06.2016 - 01.2017
- Performed hold studies for buffers' project from micro-scale to plant Transfer of Enbrel to AML-6.
- Hands-on operations, set-up, clean, sanitize and prepare media and buffers as per Standard procedures and characterization by conductivity and pH meter measurements.
- Knowledge in Protein Bulk Manufacturing like Chromatography Systems and Ultrafiltration Systems.
- Availability for resolve Troubleshooting any issues that arise, using strong data-driven decision-making processes.
- Correction and updating of the technical reports content.
- Analyzed complex data sets using statistical software to ensure research accuracy and reliability.
- Conducted experiments to support drug development processes and optimize assay protocols.
- Maintained a safe and organized laboratory environment by adhering to best practices for chemical handling and waste disposal.
- Developed and validated analytical methods to ensure accurate results in various assays.
- Maintained absolute integrity with report findings.
- Experiments were conducted in a sterile environment for the purpose of developing the product transfer method.
- Conducted experiments in laboratory environment for product development purposes.
- Documented all processes during experiments, keeping meticulous notes of changes that were unexpected.
- Participated in lab meetings and project presentations.
- Monitored and documented safety standards to verify compliance.
- Prepared reagents and solutions following standard laboratory formulas and procedures.
- Developed and validated analytical methods to assess product quality and compliance with regulatory standards.
Technical Services Specialist
PCS Validation Group in Pfizer
08.2014 - 06.2015
- Performance investigation and development of manufacturing processes with Active Pharmaceutical Ingredients.
- Review process validation and conduct investigations (QAR) and implementation of appropriate corrective actions.
- Evaluation of sampling validation testing and specifications and provided recommendations to assure the plan met compliance specifications, product registration documents and procedures.
- Evaluation of the technical content and the impact of validation deviation on product and process and provide recommendations.
- Ensured investigations of plant events are completed thoroughly and documented accurately to be included in the plant CAPA system, using five whys analysis, or investigating, quality improvement, and critical thinking, with different strategies and procedures, like Root Cause Analysis.
- It is frequently connected with Lean Manufacturing, where it is utilized to recognize and kill inefficient practices.
- It is additionally used in the examination period of the Six Sigma quality improvement technique.
- Optimize the production processes to increase yield/quality, reduce variability and reduce manufacturing costs of both new and existing processes.
- Also used Fishbone Analysis, which offers several benefits for accident research.
- It promotes a structured approach, involving multifunctional teams, to uncover the root causes.
- Organize a clear and logical structure for the responses, according to the sequence of the queries and providing references to the relevant sections of the researched API.
- Conducted risk assessments to identify potential issues in technical services operations, recommending mitigation strategies.
- On the other hand, performance impact analysis and corrective and preventive action for events, leading and participating in quality improvement programs, and assurance of cGMP.
- Determination of the need for a non-routine reprocessing documentation and evaluation of action protocols.
- Maintained comprehensive knowledge of industry best practices through continuous training programs and certifications in relevant technologies.
Professor and Laboratory Instructor of Organic Chemistry
Interamerican university Bayamon Campus
01.2011 - 05.2014
- Main duties: Professor and Laboratory Instructor of Organic Chemistry for undergraduate students.
- Evaluated student performance through assessments, providing constructive feedback to support academic growth.
- Participated in curriculum development committees, ensuring alignment with institutional goals and accreditation standards.
- Created dynamic learning environment that valued instructor and student interaction.
- Instructed and evaluated students in classroom in alignment with college mission by incorporating innovative teaching and learning strategies.
Practical training as Research Assistant
UNIVERSITY OF PUERTO RICO MAYAGÜEZ CAMPUS
06.2006 - 12.2006
- Main Duties: Synthesis of nanomaterials (e.g. Cd/S or Zn/S, Zn/O mole ratios, synthesis temperature) to optimize the corresponding photochemical performance of selected chalcogenides, not only as a function of chemical composition but also of variation in crystal size and characterization by FT-IR, UV vis., photoluminescence and Atomic Force Microscopy.
Education
Ph.D. - Applied Chemistry
University of Puerto Rico Mayagüez Campus (RUM)
Mayagüez, PR06.2013
M. S. - Chemistry
University of Puerto Rico Mayagüez Campus (RUM)
Mayagüez, PR06.2007
B. S. - Chemistry
Universidad Industrial de Santander
Bucaramanga, Colombia12.2003
Skills
- Cross-functional teamwork
- Real time analytics
- GMP knowledge
- EHS requirements, Hazwoper
- Document drafting and revision
- Problem identification and reporting
- Fishbone Analysis
- Flowcharting
- Why-Why Analysis
- Six-Sigma Analysis-DMAIC
- KPI development
- Failure mode Effects Analysis
- Fault Tree Analysis
- Hazard analysis
- Critical control Points
- Electronic Laboratory Notebook (ELN)
- Empower 30
- LIMS
- Minitab
- JMP statistical software
- Catalyst
- Track Wise system
- SAP
- Written report preparation
- Data analysis
- Materials characterization
- RAMAN (SERS)
- XRD
- FT-IR
- SEM
- PH measurement
- Conductivity measurement
- TOC measurement
- AFM
- Fluorescence
- UV Visible Spectroscopy
- Chromatography (GC, HPLC)
- Safety and hazardous waste knowledge
- Environmental policies knowledge
- Federal regulations knowledge
- Computer skills
- Organic synthesis
- Data interpretation
- Chemical analysis
- Scientific writing
- Purchasing coordination
- Technical presentations
- SAP systems
- GMP compliance
- Problem-solving abilities
- Critical thinking
- Team collaboration
- Safety protocols
- Laboratory equipment maintenance
Certification
Chemist license #6105 expiration date is November 29, 2027.
Languages
English
Professional Working
References
- Waldo Cordova Landrau, (787)- 673-2872, Electric Engineer, waldoaee@yahoo.com
- Raymond Alexander Velez, PhD in Applied Chemistry, Fresenius Kabi, raymondalexandervelez@gmail.com, (787) 245-9454
- Wanda Silva, Quality Ensure Specialist, AMGEN PR, (787)-222-9575
Academic Employment
- Universidad de Puerto Rico at Humacao, 2015-08-25, 2017-05-31, Laboratory Instructor of Organic Chemistry, Dr. Rolando Tremont, 787-850-0000 ext. 9387, rolando.tremont@upr.edu
- Interamerican University Bayamon Campus, 2011-01-01, 2014-05-31, Professor and Laboratory Instructor of Organic Chemistry, Dr. Omar Cueto, (787) 279-1912 ext 2118
- University of Puerto Rico Mayagüez Campus, 2006-06-01, 2006-12-31, Practical training as Research Assistant, Dr. Oscar Perales Pérez, operalesperez@yahoo.com
Research Thesis
- Ph. D. Research Dissertation, 2007-01-01, 2013-06-30, Low-Temperature Aqueous Synthesis of ZnO Nanorods and Coating of Au on ZnO for Enhanced RAMAN Spectroscopy Studies., Dr. Samuel Hernández Rivera, samuel.hernandez3@upr.edu
- MS Research Thesis, 2006-06-01, Detection of Nitroexplosives by Surface Enhanced Raman Spectroscopy on Colloidal Metal Nanoparticles.
Research Publications
- 2013, G. M. Herrera-Sandoval, H. Félix-Rivera, A. C. Padilla-Jimenez, M. Balaguera-Gelves, C. A. Ortega-Zúñiga, L. C. Pacheco-Londoño, O. M. Primera-Pedrozo, P. M. Fierro, C. Ríos-Velázquez, S. P. Hernández-Rivera, Synthesis and characterization of silver Nanoparticles and Nanostructure for SERS Applications, Nova Science Publishers
- 2013, Marcia del R. Balaguera-Gelves, Oscar J. Perales-Pérez, Surinder P. Singh, José A. Jiménez, Joaquín A. Aparicio-Bolaños, Samuel P. Hernández-Rivera, Improved Low Temperature Aqueous Synthesis of ZnO Nanorods and their Use in SERS Detection of 4-ABT and RDX, Materials Science and Applications, 2013-01-24
- 2011, N. Palomera, M. Balaguera, S. K. Arya, S. P. Hernández, M.S. Tomar, J. E. Ramírez, S. P. Singh, Zinc Oxide Nanorod Films for Electrochemical Urea Biosensor, Material Research Society Symposium Proceeding
Contributions To Conferences
- ZnO Rods Coated with Au for Enhanced Raman Spectroscopy, XVI SIGMA XI POSTER, 2011-04-12, UPR-Mayagüez
- Low Temperature Aqueous Synthesis of ZnO nanorods for Enhanced Raman spectroscopy, Nanoelectronic Devices for Defense and Security Conference, 2009
Professional Services
2008, Scientific Fair Poster session, Mentor for project titled 'Comparative study cadmium sulfide and cadmium sulfide nanocrystals optical properties'., San Juan Puerto Rico
Timeline
Laboratory Chemist
GENERAPR
07.2023 - 06.2025
Chemist, Shift Supervisor
Puerto Rico Electric Power authority
06.2020 - 06.2023
External/Internal Complaint Analyst
Fresenius Kabi
07.2019 - 10.2019
Scientist
RCM Technologies, Inc/Thermofisher
09.2018 - 07.2019
CW-GMP03 Associate Scientist/ Process Development
Amgen
06.2016 - 01.2017
Laboratory Instructor of Organic Chemistry
Universidad de Puerto Rico at Humacao
08.2015 - 05.2017
Technical Services Specialist
PCS Validation Group in Pfizer
08.2014 - 06.2015
Professor and Laboratory Instructor of Organic Chemistry
Interamerican university Bayamon Campus
01.2011 - 05.2014
Practical training as Research Assistant
UNIVERSITY OF PUERTO RICO MAYAGÜEZ CAMPUS
06.2006 - 12.2006
M. S. - Chemistry
University of Puerto Rico Mayagüez Campus (RUM)
B. S. - Chemistry
Universidad Industrial de Santander
Ph.D. - Applied Chemistry
University of Puerto Rico Mayagüez Campus (RUM)