Belithza Santos
Isla Verde #328 Villas De La Playa Vega Baja
Summary
I seek a challenging position in a dynamic, progressive, and growth-oriented company. I am a self-starter, able to form good working relations with my co-workers, and very firm but fair in the decision-making process.
Licensed Chemist with 25 years of pharmaceutical industry experience. I have worked in all laboratory areas; Raw Material, Finished, and Stability. In recent years I worked for QA Batch record review in the Disposition area. Throughout my professional career, I have been asked to assist in multiple areas even when not a part of that specific department. For example, generating and validating a COA for QA lot release or documentation review and archiving.
Overview
2026
2026
years of professional experience
1
1
Certification
Work History
Quality Auditor
Avara
Arecibo
02.2025 - Current
- Tracked quality metrics such as defect rate, rework rate, waste rate.
- Reviewed supplier documentation to assess compliance with requirements.
- Assisted in developing strategies for improving overall customer satisfaction.
- Inspected incoming materials for conformance to specifications.
- Conducted internal audits to ensure compliance with quality standards.
- Collaborated with production staff to resolve quality issues in a timely manner.
- Analyzed data from customer surveys and suggested solutions for improvement.
- Maintained all relevant documents related to inspections and audits in an organized manner.
- Monitored product performance and identified areas for improvement.
- Created reports on audit findings, including recommendations for improvements.
- Developed and maintained audit plans, checklists and procedures.
- Evaluated production processes for efficiency and effectiveness.
- Ensured that all products meet statutory regulations before being released into the market.
QA Specialist
Viatris
Barceloneta
01.2024 - 12.2024
- Company Overview: Pharmaceutical Industry
- Responsible for auditing and approving Batch Records of complete manufactures, making products available for different markets.
- We work with great care and dedication, putting data integrity first.
- The operational systems I manage daily are SAP, LIMS, MES, Trackwise, Decision, D2.
- Each of the systems plays a role within our responsibilities that allows us to work and make decisions.
- Pharmaceutical Industry
QC Specialist
Bacardi corp.
Cataño
01.2024 - 12.2024
- Company Overview: Food Industry
- Responsible for ensuring the quality of the rum.
- Carrying out all the chemical analyses that were required and following each step throughout the creation of the rum.
- Taking care every detail of the age rum and balancing flavours.
- Analyzing every impurity that the fermentation process could have so as not to alter the product and its quality.
- In this way I ensured that the product that arrived at the table was one of absolute quality.
- Food Industry
QA Scientist
Bristol Meyer Squib
Manatí
01.2022 - 12.2023
- Company Overview: Pharmaceutical Industry
- The Batch Record audit reviewed the entire manufacturing process, including Formulation, Filling, Packaging and Inspection.
- This audit consists of verifying that each form, document or process is properly documented and meets the product specification.
- It was verified that all documents were signed, dated, open space obliterated and everything was within specification.
- As part of this audit, it was also verified that what was done and written on paper was what was in the system.
- Within each stage were the laboratory tests of Analytical, Environmental and Microbiology, which were different for each market.
- All documents were reviewed so that they complied with Data Integrity Plus and each regulation of the different agencies.
- It is important to note that all the data was physical, but also electronic, so I worked with software such as DCA, SAP, Infinity, Maximo, LIMS, MODA.
- Each part was meticulously audited to leave no details behind.
- Pharmaceutical Industry
Scientist II
Thermo Fisher Scientific
Manatí
01.2008 - 12.2020
- Company Overview: Pharmaceutical Industry
- I started in 2008 in the stability area, working for 4 years with the coordination of samples that were added to the program.
- In stability I was responsible for reporting the statical table and for doing the pull according to the schedule.
- Work doing analysis of samples such as impurities, assay, dissolution.
- Then I went to the method transfer area or Analytical Services, where I had the opportunity to work with the execution of protocol, metrics, and statistics about the testing.
- I worked on all kinds of assessments for new products.
- As part of the task, audit method transfer protocols and equipment qualification.
- I may perform import entry review requiring decisions to release or detain regulated commodities based on document review.
- As a Licensed Chemist, I’ve also worked reviewing, revising and approving laboratory data, operational protocols, and SOPs.
- Then I went to the In-process area where I was responsible for the cleaning process intermediate in the final product.
- Finally, I worked: HPLC, GC, IR, UV.
- Ending 2020 just when the pandemic began at that time, I was working for the area of method development and equipment validation, PQ, OQ, and administrative SOPs.
- During this time I worked with the transfer of a product from the East, generating protocols and method for additional analysis evaluating the purchase of equipment and materials.
- Pharmaceutical Industry
Senior Laboratory Analyst
Recoms Laboratories, INC
Humacao
01.2006 - 12.2007
- Company Overview: Pharmaceutical Industry
- As a Senior, I was responsible for coordinating laboratory tasks, receiving samples, assigning special jobs, writing investigations in trackwise, and maintaining laboratory metrics and trends.
- Should make a daily report of the sample that arrived vs those that were analyzed.
- Implemented CAPAs if necessary, in investigations.
- Among other responsibilities was keeping the laboratory organized and clean, everything well documented and labeled.
- Assign work to auditors and monitor unreported data.
- Pharmaceutical Industry
Raw Material Analyst
Pharmacia-Pfizer
Barceloneta
01.2001 - 12.2006
- Company Overview: Pharmaceutical Industry
- Perform testing such as API (Active product ingredient), raw material testing and stability.
- In that moment I worked with water sample analysis, TOC, Conductivity, Oxidizing substance and many other tests for raw materials.
- I worked with all equipment: Polarimeter, UVvis, IR, GC, HPLC, Densitometer, KF, Potentiometric titrator, K value.
- Pharmaceutical Industry
Quality Auditor
Avara
Education
MBA - Projects Management
Ana G. Mendez University
Cupey, PR05-2025
Bachelor’s degree - chemistry
Interamerican University of Puerto Rico
Cupey, PR05-2000
Skills
- Laboratory regulatory compliance
- Project management
- Effective communication
- Regulatory compliance
- Problem solving
- Attention to detail
- Statistical analysis
- Quality assurance
- Pharmaceutical analysis
- Change control generation
- HPLC and GC
- UV/Vis spectroscopy
- FTIR and AA analysis
- Limit of detection
- Identification techniques
- Polarimetry and pH testing
- Total organic carbon analysis
- Microsoft Office Suite
- SAP and LIMS proficiency
- Empower 3 and 4 software
- CGMP and CGLP standards
- CFR compliance
- OSHA regulations
- FDA regulations and SOPs
- USP/NF, JP, FCC, EP/BP guidelines
- Protocol generation and validation reporting
Certification
- Puerto Rico Chemist License No., 4727
- Research in the Biochemical Properties of Soybean Lipoxygenase-1
- OSHA Certificate
Date Available
Immediately
Languages
Spanish
First Language
English
Advanced (C1)
C1
References
References available upon request.
Timeline
Quality Auditor
Avara
02.2025 - Current
QA Specialist
Viatris
01.2024 - 12.2024
QC Specialist
Bacardi corp.
01.2024 - 12.2024
QA Scientist
Bristol Meyer Squib
01.2022 - 12.2023
Scientist II
Thermo Fisher Scientific
01.2008 - 12.2020
Senior Laboratory Analyst
Recoms Laboratories, INC
01.2006 - 12.2007
Raw Material Analyst
Pharmacia-Pfizer
01.2001 - 12.2006
Quality Auditor
Avara
MBA - Projects Management
Ana G. Mendez University
Bachelor’s degree - chemistry
Interamerican University of Puerto Rico
Similar Profiles
Erin AnsleyErin Ansley
Customer Engagement and Experience at AvaraCustomer Engagement and Experience at Avara
YARIELIZ Y. RODRÍGUEZYARIELIZ Y. RODRÍGUEZ
Batch Record Reviewer at AVARABatch Record Reviewer at AVARA
Seth Adjei KesseSeth Adjei Kesse
Production worker at Avara FoodsProduction worker at Avara Foods
Andrea Ramos Ahmad, DVM Andrea Ramos Ahmad, DVM null
Veterinary Assistant at Clinica Veterinaria PadovaniVeterinary Assistant at Clinica Veterinaria Padovani
Geomar AbreuGeomar Abreu
Agency Owner at Dominican Web Designs AgencyAgency Owner at Dominican Web Designs Agency