YANITZIA M. RIVERA BURGOS
PONCE
Summary
Professional with strong experience in Quality Assurance in the Pharmaceutical Industry. Knowledge in GMP’s, GLP’s, SOP’s, OSHA Regulations. Excellent communications skills and teamwork oriented. Good interpersonal skills and hard working individuals. Able to handle multiple priorities. Proactive with ability to interact at different levels. Highly organized and dedicated with a positive attitude. Problem solving capabilities. Ability to work under pressure Computer literacy in Microsoft Office (Word, Excel, Power Points), Expertise in Perkin Elmer’s Turbochrom, Peak Pro and Waters Empower, and LIMS.
Overview
24
24
years of professional experience
Work History
Team Leader: Validation Laboratory
Janssen Pharmaceutical
01.2016 - Current
- Company Overview: (Kelly OCG)
- Coordinate laboratory analyses in order to comply with Protocols schedule and due dates
- Maintain an effective communication with the client (Janssen supervisors and manager) to ensure clear expectations
- Continuously improve job workflow, procedures, and task to improve efficiency
- Ensure that suitable written records and data are generated in accordance with cGMP’s and Company Procedures
- Involves and engage employees through process improvement discussions, follow-up on suggestions, and regular communication
- Ensure proper training, coaching, and feedback between employees
- Collaborated with other department leaders to establish shared goals and ensure alignment across teams.
- Established open and professional relationships with team members to achieve quick resolutions for various issues.
- Set performance expectations for the team, monitoring progress towards goals and providing constructive feedback as needed.
- Empowered team members by delegating responsibilities according to individual strengths and areas of expertise.
- Maintained an inclusive and diverse team culture, promoting respect and understanding among all members.
- Managed conflict resolution among team members, fostering a positive and collaborative work environment.
- Enhanced team productivity by implementing efficient work processes and regularly reviewing performance metrics.
Laboratory Analyst: Quality Control Laboratory
Janssen Pharmaceutical
07.2014 - 01.2016
- Company Overview: (Kelly Scientific)
- Perform procedures to Quality Control, including High Performance Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), Karl Fischer (KF), Fourier Transform Infrared Spectroscopy (FTIR), pH testing
- Perform analysis such as Heavy Metal, Residue of Ignition, HPLC analysis for API for Raw Material Area; for Finish Products Area perform Dissolutions, Content Uniformity, Assay, Peroxide test (UPLC)
- Read and interpreted analytical methods and procedures, and acquired safety rules knowledge
- Keep laboratory records with high levels of accuracy following Good Manufacturing Practices (GMPs)
- Interpreted and reported test results to stakeholders, providing insights for decision-making processes.
- Utilized advanced analytical instruments to conduct complex experiments and gather critical data.
Laboratory Analyst; Quality Control Laboratory
PharmaBioserv
07.2013 - 03.2014
- Company Overview: (Contractor) Procter and Gamble
- Conduct water sampling (USP & RO) for the manufacturing process and run the analysis required (Appearance, Conductivity, Odor Test and TOC) to ensure quality and regulatory compliance
- (Contractor) Procter and Gamble
Laboratory Supervisor and Accounting Clerk
Serrallés Environmental Technologies Inc.
07.2005 - 03.2012
- Participated during the start up of the wastewater treatment plant
- Created the SOP’s for Serralles Environmental Technologies wastewater treatment plant laboratory
- Oversaw the validation of the laboratory, qualification of equipment and validation of methods
- Carried out analysis of water such as COD, BOD, TSS, Nitrate, Phosphorous, Ammonia, Sulfur and Sulfate
- Organized and assigned the daily work and data interpretation to optimize the wastewater treatment process
- Collaborated as a part of the implementation of a new ERP (Enterprise Resource Planning) system named PLEX
- Responsible of production, Maintenance Department and laboratory purchases orders (PO’s); Billing and dispatch
- Responsible of creating an organization system that made the production more fluent and effective
Laboratory Analyst; Quality Control Laboratory
Bristol Myers Squibb
03.2004 - 04.2005
- Being part of the Finish Product Team
- Developed a strong ability in the use of laboratory instruments, especially HPLC
- Accomplished in Peak Pro and training of Waters Empower
- Performed analysis such as Dissolutions, Content Uniformity, Assay and TLC tested for all the product of Finish Product Area
Laboratory Analysts; Quality Assurance Laboratory
Wyeth Pharmaceutical Company
01.2001 - 02.2004
- Being part of the Finish Product (Oral Contraceptive Team)
- Obtained knowledge in the use of laboratory instruments, such as HPLC, IR, UV/Vis
- Expertise in Perkin Elmer’s Turbochrom
- Ability to perform analysis such as Dissolutions (also suppositories), Content Uniformity, Assay, Degradations, TLC, LOD, Hardness and Friability test for tablets
- I was also part of the Validations, Methods Transfer, Raw Material, Stability areas, and Data Reviewer team
- Read and interpreted analytical methods and procedures, and acquired safety rules knowledge
Education
Bachelor Degree - Sciences – Chemistry
Pontifical Catholic University of Puerto Rico
Ponce, PRMaster in Business Administration (iMBA) -
Universidad De Puerto Rico
Rio Piedras, PR01.2025
Skills
- Teamwork and collaboration
- Problem-solving
- Attention to detail
- Team motivation
- People management
- Work Planning and Prioritization
- Team supervision
- Goal setting
- Conflict resolution
- Client support
Licnumber
Q05126
Professionaltrainingsandaccomplishments
- Certified by Validation Industry Training Program.
- Analyst Certification Program.
- Chemist License of Puerto Rico.
- Trained new personnel in Quality Assurance department.
- Supervising experience for over nine years.
Languages
English
Limited Working
Timeline
Team Leader: Validation Laboratory
Janssen Pharmaceutical
01.2016 - Current
Laboratory Analyst: Quality Control Laboratory
Janssen Pharmaceutical
07.2014 - 01.2016
Laboratory Analyst; Quality Control Laboratory
PharmaBioserv
07.2013 - 03.2014
Laboratory Supervisor and Accounting Clerk
Serrallés Environmental Technologies Inc.
07.2005 - 03.2012
Laboratory Analyst; Quality Control Laboratory
Bristol Myers Squibb
03.2004 - 04.2005
Laboratory Analysts; Quality Assurance Laboratory
Wyeth Pharmaceutical Company
01.2001 - 02.2004
Bachelor Degree - Sciences – Chemistry
Pontifical Catholic University of Puerto Rico
Master in Business Administration (iMBA) -
Universidad De Puerto Rico
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