Yanitza Montalvo
Arecibo ,Puerto Rico
Summary
Quality assurance professional with extensive expertise in batch record review, technical writing proficiency, and CAPA system understanding. Demonstrates strong competency in root cause analysis and quality control tools usage. Adept at implementing Quality Management Systems and conducting thorough quality inspections to ensure compliance with industry standards. Career goal includes advancing within the field of quality assurance to drive continuous improvement and operational excellence.
Overview
6
6
years of professional experience
3
3
years of post-secondary education
Work history
Quality Control Technitian
Baxter
Jayuya , Puerto Rico
2024.09 - Current
- Collaborated with the production team, achieving smoother operations.
- Coordinated calibrations of instruments to ensure accurate readings.
- Implemented new protocols for increased safety compliance.
- Ensuring the execution of a range of tests, including bacterial endotoxin (gel clot and kinetic), sterility test, bioburden/microbial limit, growth promotion, particulate matter analysis for parenteral products, microbial identification, pH testing, and other pertinent analyses linked to the release of manufactured goods.
- Executing assays and thorough microbial analyses of manufacturing utilities such as water, clean condensate, compressed air, and nitrogen
- Overseeing the meticulous preparation and sterilization of materials necessary for analysis, including culture media, and the dehydrogenation/sterilization of glassware.
- Monitoring the environmental conditions at aseptic and oral dosage form manufacturing and packaging facilities, encompassing both viable (air, surface, and personnel) and non-viable elements.
- Performing audits of aseptic techniques and promoting appropriate conduct within the controlled manufacturing environment.
- Documenting and addressing inadequate behavior and implementing corrective actions as necessary.
- Responsible for performing the raw materials and finished product required sampling and testing.
- Responsible for maintaining the necessary testing supplies in stock.
- Responsible for managing the media inventory. Providing the ability to generate purchasing requisitions as required will directly impact the efficiency of our testing process.
- Responsible for collecting, testing, and reviewing routine test results for release.
- Responsible for the approval and release of sterilized products.
- Responsible for executing investigations of out-of-specified test results for environmental and laboratory assays.
- Responsible for providing technical review and disposition of raw materials, in-process, and finished goods.
- Conducting audits to assess the physical conditions and housekeeping standards in controlled areas and utilities, and initiating corrective actions as required.
- Responsible for evaluating and testing raw materials and finished products to ensure quality standards/compliance with customer and regulatory requirements.
- Responsible for laboratory investigations and deviations, ensuring thorough documentation, root cause analysis, and compliance with GMP and internal quality standards.
- Interpreted test results for quick problem-solving decisions.
- Identified and rectified issues, preventing costly errors.
- Streamlined testing procedures for improved efficiency.
- Maintained product quality by conducting regular inspections.
Quality Control II
Sanofi
Framingham, Boston, Mass
2022.04 - 2024.09
- Conducted comprehensive risk assessments to anticipate potential challenges.
- Initiated process improvements that significantly enhanced workflow efficiency.
- Responsible for consistent and thorough investigation of exception events, documentation, and timely resolution of exception documents based on CAPA requirements.
- Responsible for monitoring and continuous improvements of the CAPA quality system.
- Responsible for performing exception reports, complaints, PQRs, Change Plan coordination, and trend monitoring systems, assuring compliance with company policies, plant procedures, and regulations.
- Responsible for ensuring that exception documents are written according to Operations policies, Client procedures, and regulatory requirements.
- Responsible for managing the exception event investigation process to ensure all aspects of the exception event are investigated, and the root cause is determined.
- Conducted comprehensive analyses of product impact, leading to informed recommendations regarding implications of exception events.
- Implemented corrective actions to address issues and prevent recurrence.
- Responsible for ensuring exception event reports are approved on time as required by polices and regulatory requirements.
- Responsible for ensuring that all CAPAs determined through the investigation process are implemented on time in compliance with policies and regulatory requirements.
- Responsible for assessing the effectiveness of CAPAs in compliance with policies and regulatory requirements.
- Responsible for evaluating and managing exception events across manufacturing, microbiology, and stability areas, ensuring all investigations were executed in strict accordance with company SOPs and global regulations.
- Performed robust technical assessments to ensure accurate identification of primary root causes behind out of specification and out of trend laboratory results.
- Responsible for authoring comprehensive investigation reports, documenting impact assessments, and providing data-driven recommendations for product disposition.
- Responsible for defining and implementing effective Corrective and Preventive Actions (CAPA) to mitigate risks and prevent the recurrence of quality deviations.
- Responsible for monitoring the effectiveness of implemented actions, driving continuous improvement within the CAPA quality system.
- Responsible for ensuring full compliance with USP, FDA, and internal plant procedures during all laboratory and complaint investigations.
- Responsible for facilitating internal and external audits, serving as a primary point of contact for investigation-related inquiries and documentation.
- Responsible for trend monitoring and generating periodic trend reports and quality metrics to identify adverse patterns and drive proactive system enhancements.
- Responsible for PQR generation, compiling and approving annual product reviews, and ensuring all statistical trends are aligned with established quality standards.
- Responsible for investigating activities when an exception event occurs in manufacturing, incoming laboratory, Quality Control laboratory, validation, microbiology, stability, or complaints area.
- Conduct thorough investigations of exception events to ensure compliance with CAPA requirements.
- Responsible for performing complaint investigations, ensuring compliance with policies, procedures, and regulatory requirements.
- Responsible for performing laboratory investigations when out-of-specification or trend results are reported.
- Managed multiple assignments simultaneously under strict deadlines, showcasing strong organisational and time management skills.
- Applied critical thinking to analyse problems, evaluate solutions and select best decisions.
Quality Assurance Inspector
Eaton
Arecibo, Puerto Rico
2020.10 - 2021.11
- Responsible for evaluating raw materials, in-process components, and finished goods using precision measuring instruments (calipers, micrometers, and gauges) to ensure 100% conformance to technical blueprints and bill of materials.
- Responsible for identifying and isolating non-conforming materials and executing immediate containment protocols to prevent downstream contamination or defective shipments.
- Conduct high-volume visual and functional testing under stringent timelines while ensuring exceptional accuracy.
- Ensured comprehensive maintenance of electronic and manual batch records to uphold data integrity and facilitate readiness for audits.
- Validated all inspection equipment to ensure compliance with calibration cycles, documenting deviations and coordinating adjustments with the metrology department.
- Responsible for generating detailed daily quality reports (DQR) to summarize inspection findings, highlighting critical defects and emerging quality trends for management review.
- Responsible for adherence to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) on the production floor, providing real-time feedback to operators to correct procedural drifts.
- Responsible for monitoring critical process parameters (CPPs) to ensure manufacturing environments remained within validated ranges.
- Performed detailed assessments through gemba walks and "5-why" sessions alongside engineering and production teams, ensuring thorough identification of root causes for recurring defects.
- Responsible for the implementation of Pilot runs for new product designs, providing critical feedback on manufacturability and inspection feasibility.
- Facilitated review boards to provide technical input on the disposition of items classified as 'use-as-is', 'rework', or 'scrap'.
- Optimized automated inspection processes to minimize human error and enhance throughput.
- Responsible for the authority to accept or reject materials, subassemblies, assemblies, and processes that affect the quality and safety of products.
- Responsible for checks on material disposition and identification to meet GMP regulations.
- Responsible for inspecting and documenting inbound raw materials for conformance.
- Responsible for performing process, dimensional, and visual inspection to ensure compliance with company SOP.
- Responsible for documentation of (in-process) sampling plan, disposition, and inspection results.
- Perform audits in assigned areas to enhance operational integrity and maintain quality control.
- Facilitate training sessions for operators focusing on product quality requirements to promote consistent adherence.
- Responsible for reporting any defect found to the quality supervisor.
- Responsible for providing feedback to employees on defects found to ensure the quality of our product.
- Responsible for placing non-conforming products on hold and creating non-conforming records.
- Conduct quality inspections on rework products to ensure compliance with standards.
- Executed departmental procedures to ensure adherence to standards for routine daily assignments.
- Facilitate smooth material flow and storage for inspected parts.
- Support accurate inventory tracking and management.
- Operated various tools and gauges, including digital calipers and micrometers, to systematically obtain product specification data.
- Assist with mechanical and electrical testing using calipers and gauges.
Education
Bachelor of Science - Biology
Interamerica de Arecibo
Puerto Rico 2013.08 - 2016.08
Master of Science - Medical Science
Ana G Mendez
Carolina 2026.01 -
Skills
- Batch record review
- Technical writing proficiency
- Root cause analysis competency
- Quality control tools usage
- GMP & quality systems knowledge
- Quality assurance expertise
- Quality inspection
- Bilingual (English/Spanish) with strong writing skills
- Microscope proficiency
- Strong problem-solving & multitasking skills
- Strong experience in CAPA & investigations
References
References available upon request.
Timeline
Master of Science - Medical Science
Ana G Mendez
2026.01 -
Quality Control Technitian
Baxter
2024.09 - Current
Quality Control II
Sanofi
2022.04 - 2024.09
Quality Assurance Inspector
Eaton
2020.10 - 2021.11
Bachelor of Science - Biology
Interamerica de Arecibo
2013.08 - 2016.08