Leonardo Ramos Rivera
Mayaguez
Summary
Quality Assurance Professional with extensive expertise in QMS implementation and audit management. Proven ability to ensure regulatory compliance and enhance operational efficiency across multi-site biotech operations. Strong track record of reducing audit findings and fostering a quality-driven culture. Highly adaptable and results-oriented, with a commitment to continuous improvement and problem-solving.
Overview
17
17
years of professional experience
3
3
Certifications
Work History
Quality Assurance Infrastructure Lead
CDI Laboratories Inc.
Mayaguez, Baltimore, Puerto Rico, Maryland
01.2024 - Current
- Strategic Leadership: Direct the comprehensive Quality Management System (QMS) for a multi-site biotech operation, ensuring continuous compliance with ISO 27001, ISO 13485, and international regulatory standards.
- Compliance & Auditing: Serve as the primary regulatory compliance authority; manage and execute internal/external audits, specifically spearheading the implementation and management of the ISO 27001 Information Security Management Standard.
- Infrastructure Management: Managed the planning, execution, and oversight of building facility construction and repair initiatives, ensuring validated infrastructure readiness for laboratory operations.
- Validation & QA: Conduct robust Computer System Validation (CSV) and maintain ongoing Equipment Installation, Operation, and Performance Qualification (IQ/OQ/PQ) across critical lab instrumentation.
- Stakeholder Communication: Facilitate monthly Quality Management Review Meetings and Executive Quality briefings, delivering quarterly insights and quality metrics to stakeholders for data-driven business decisions.
- Operational Support: Oversee Site Environmental Health & Safety and Physical Security; manage essential lab supply procurement.
- Audit Hosting: Successfully hosted and managed multiple 3rd party audits for Quality and Compliance, ensuring minimal findings and prompt remediation. Executed internal compliance audits.
- Achieved cost-savings by developing functional solutions to problems.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Prioritized and organized tasks to efficiently accomplish service goals.
- Worked with cross-functional teams to achieve goals.
- Completed day-to-day duties accurately and efficiently.
Lead, Quality Assurance / Associate Operations Manager
CDI Labs
Mayaguez, Baltimore and Toronto, Puerto Rico, Maryland and Canada
01.2023 - 01.2024
- QMS Implementation: Transitioned from a QA specialist role to leading the Quality Assurance department, formalizing and managing the Quality Management System across the organization.
- Audit Hosting: Successfully hosted and managed multiple 3rd party audits for Quality and Compliance, ensuring minimal findings and prompt remediation. Executed internal compliance audits.
- Training & Development: Developed and delivered company-wide training on quality and compliance standards, significantly improving workforce adherence and quality culture.
- Procedure Development: Developed and rigorously reviewed Quality Assurance procedures, Standard Operating Procedures (SOPs), and work instructions for instruments and methods.
- Infrastructure Management: Managed the planning, execution, and oversight of building facility construction and repair initiatives, ensuring validated infrastructure readiness for laboratory operations.
- Operational Support: Oversee Site Environmental Health & Safety and Physical Security; manage essential lab supply procurement and equipment maintenance coordination.
- Facilitated training sessions for staff on quality control practices.
- Assisted in identifying areas for process improvement within the lab.
- Participated in internal audits to evaluate compliance with quality protocols.
- Researched and explored quality issues to report compliance.
- Conducted audits of internal operations to ensure compliance with established policies and procedures.
- Developed and maintained Quality Assurance processes, procedures, and standards.
- Improved productivity initiatives, managing budgets and accounts, coordinating itinerary and scheduling appointments.
- Coordinated cross-functional teams to ensure timely delivery of products and services.
- Established effective relationships with vendors to negotiate pricing and secure materials needed for production.
- Collaborated with team leaders on quality audits.
- Developed and implemented operational procedures to ensure quality standards are met.
- Implemented policies and standard operating procedures and managed quality, customer service and logistics.
Quality Assurance / Associate Operations Manager
CDI-Labs
Mayaguez, Baltimore, Puerto Rico, Maryland
01.2021 - 01.2023
- QA: Evaluated and maintained the regulatory compliance posture of all CDI products and processes.
- Operational Support: Oversee Site Environmental Health & Safety and Physical Security; manage essential lab supply procurement and equipment maintenance coordination.
- Procedure Development: Developed and rigorously reviewed Quality Assurance procedures, Standard Operating Procedures (SOPs), and work instructions for instruments and methods.
- Infrastructure Management: Managed the planning, execution, and oversight of building facility construction and repair initiatives, ensuring validated infrastructure readiness for laboratory operations.
- Training & Development: Developed and delivered company-wide training on quality and compliance standards, significantly improving workforce adherence and quality culture.
- Audit Hosting: Successfully hosted and managed multiple 3rd party audits for Quality and Compliance, ensuring minimal findings and prompt remediation. Executed internal compliance audits.
- Collaborated with cross-functional teams to address quality concerns and improve processes.
- Developed and maintained quality assurance documentation and standard operating procedures.
- Tested software applications to identify defects and verify functionality before release.
- Implemented corrective actions based on root cause analysis of quality issues.
- Trained new employees on quality assurance protocols and best practices.
- Monitored production processes for adherence to established quality benchmarks.
- Assisted in audits by providing necessary documentation and evidence of compliance.
- Researched and explored quality issues to report compliance.
- Collaborated with stakeholders to identify, investigate, and verify complex records and potential risk issues.
- Documented any deficiencies discovered during inspections or reviews of operational activities.
- Coordinated with suppliers regarding product compliance, testing, and certification requirements.
- Created training materials for employees on Quality Assurance topics such as inspection techniques and process validation protocols.
- Developed and maintained Quality Assurance processes, procedures, and standards.
- Investigated non-conformance reports to identify corrective action plans.
- Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
- Inspected, removed and replaced malfunctioning equipment and tools to minimize workflow disruptions.
- Reorganized and revised standard operating procedures to streamline processes and improve communication and collaboration.
Quality Assurance / Associate Operations Manager / Animal Resource Scientist
CDI-Labs
Mayaguez, Baltimore, Puerto Rico, Maryland
01.2015 - 01.2021
- Instrumental in the early implementation and management of the QMS.
- Managed essential logistics, including the procurement and distribution of crucial lab supplies.
- Trained new associates on quality control procedures and best practices in testing.
- Assisted in the development of training materials for quality assurance processes.
- Monitored equipment performance and reported discrepancies to maintenance teams promptly.
- Participated in internal audits to assess compliance with regulatory requirements and standards.
- Managed laboratory inventory and ensured compliance with safety regulations.
- Engaged in continuous learning to stay abreast of advances in the scientific field.
- Authored and co-authored research papers for publication in peer-reviewed journals.
- Maintained field equipment and performed troubleshooting techniques to keep tools fully operational.
- Managed laboratory equipment and ensured compliance with safety protocols.
- Conducted regular reviews of existing policies and procedures for continuous improvement opportunities.
- Produced SOPs to document workplace procedures and optimize productivity through standardization.
- Established effective relationships with vendors to negotiate pricing and secure materials needed for production.
- Created detailed reports on the performance of individual departments within operations.
- Collaborated with team leaders on quality audits.
- Managed scheduling, training and inventory control.
- Participated in technical trainings and workshops to improve skills set and boost overall knowledge.
- Identified and troubleshot equipment problems.
- Consistently performed Equipment Installation, Operation, and Performance Qualification (IQ, OQ, PQ).
- Manages and executes Laboratory animal processes.
- Managed the planning, execution, and oversight of building facility construction and repair initiatives, ensuring validated infrastructure readiness for laboratory operations.
- Conducted thorough quality inspections on laboratory products and equipment.
- Collaborated with cross-functional teams to address quality assurance issues.
- Participated in cross-functional teams focused on developing solutions for identified quality issues.
- Monitored production activities to verify that products are produced in accordance with specified requirements.
- Developed and maintained Quality Assurance processes, procedures, and standards.
- Collaborated with management to discuss effective plans for resolving major quality problems.
- Received and inspected raw materials.
- Maintained lab cleanliness and safety standards.
- Coordinated daily operations across multiple departments to ensure workflow efficiency.
- Managed inventory control processes to optimize supply chain performance.
- Developed and implemented standard operating procedures for operational consistency.
- Trained staff on best practices for safety and operational protocols.
- Maintained accurate inventory records to track stock levels and minimize costs.
- Performed cost analysis for various projects to determine budget requirements.
- Prepared staff work schedules and assigned team members to specific duties.
- Delegated work to staff, setting priorities and goals.
- Conducted experiments to test hypotheses and validate scientific theories.
- Maintained accurate records of experimental protocols and results in accordance with regulatory requirements.
- Created and maintained spreadsheets and databases to detail specimen collection and data gathering.
- Collaborated with other departments within the organization on cross-functional initiatives related to research projects.
- Conducted experiments for product development purposes in laboratory settings.
- Participated in weekly team meetings to discuss progress towards project goals and collaborate on solutions.
- Shared research findings through publications, presentations and conferences.
- Conducted literature reviews to support research projects and identify new areas of exploration.
- Developed project timelines and schedules, prioritizing tasks for entire team of professionals.
- Applied knowledge of mathematics, physics, chemistry and biology to support research and experiments.
- Monitored laboratory equipment performance, performed repairs, calibrations, and preventative maintenance as necessary.
- Met pertinent milestones while managing multiple projects at once.
- Supervised junior scientists and laboratory technicians, providing mentorship and training.
- Negotiated contracts with external vendors for laboratory supplies and services.
- Recommended new systems and processes to improve operations.
Animal Resource Scientist / Associate Operations Manager
CDI-Labs
Mayaguez
01.2009 - 01.2015
- Key player in the successful launch and business growth of the startup. Managed equipment maintenance and was a certified CPR/First Aid Responder. Formulate an immunization methodology.
- Developed and validated protocols for laboratory procedures and techniques.
- Managed laboratory equipment maintenance and calibration for optimal performance.
- Documented research findings in comprehensive reports for regulatory compliance.
- Maintained accurate records of experimental protocols and results in accordance with regulatory requirements.
- Collaborated with senior management to define objectives, goals and metrics for evaluating success of operations initiatives.
- Assisted in developing budgets for operations department and monitored expenses against budget limits.
- Managed inventory levels through accurate forecasting techniques.
- Resolved conflicts between teams or individuals arising out of work related issues.
- Collaborated with cross-functional teams to support project execution.
- Oversaw inventory management and maintained supply chain efficiency.
- Managed laboratory inventory and ensured compliance with safety regulations.
- Authored and co-authored research papers for publication in peer-reviewed journals.
- Negotiated contracts with external vendors for laboratory supplies and services.
- Prioritized workloads with department team.
- Met pertinent milestones while managing multiple projects at once.
- Prepared budgets for each project and managed resources to keep tasks on track.
- Monitored laboratory equipment performance, performed repairs, calibrations, and preventative maintenance as necessary.
- Maintained field equipment and performed troubleshooting techniques to keep tools fully operational.
- Conducted experiments to analyze chemical properties and reactions.
- Developed protocols to ensure safety and compliance in laboratory settings.
- Collaborated with cross-functional teams to support research initiatives.
- Managed inventory and ordered supplies for laboratory operations.
- Trained junior scientists on best practices and laboratory techniques.
- Documented findings in reports for peer review and regulatory submissions.
- Created and maintained spreadsheets and databases to detail specimen collection and data gathering.
- Developed reports and recommendations regarding research outcomes.
- Collaborated with undergraduate and graduate students to provide research guidance and supervision.
Education
Bachelor of Science - General Agriculture Science, Minor in Biology
University of Puerto Rico
Mayaguez, Puerto Rico01.2011
Skills
- QMS implementation & management (ISO 9001/13485/27001)
- Audit management (internal/external)
- Computer system validation (CSV)
- Equipment qualification (IQ, OQ, PQ)
- Environmental health and safety (EHS)
- Procurement & supply chain
- Business continuity planning
- Agile methodologies
- Friendly, positive attitude
Affiliations
- American Society for Quality (ASQ), Puerto Rico Chapter Volunteer, 01/01/25 - Present
- Society of Quality Assurance (SQA), Attended 2024 Annual Meeting, 01/01/24
- Research Quality Association (RQA), 01/01/24
Continuing Education Training
- Project Management: Foundations and Initiation, Coursera, 10/01/25 - ongoing
- The Good Auditor (Auditing Soft Skills), SQA, 01/01/25
- Computer System Validation Basics, Validation Center, 01/01/25
- Understanding Uncertainty and Other Calibration Issues, ASQ Puerto Rico Section, 01/01/24
- Data Integrity for Computer Systems Auditors, SQA, 01/01/23
- FDA GLP Compliance Program for Staff, SQA, 01/01/23
- Risk Assessment process, Disaster recovery, and Business Continuity, SQA, 01/01/23
- CGMP QMS 8-Hour Boot Camp Webinar, GMP Boot Camps Life Style Practice, 01/01/21
- Good Laboratory Practice (GLP), RQA, 01/01/22
Publications
- Rapid identification of monospecific monoclonal antibodies using a human proteome microarray, Jeong JS, Jiang L, Albino E, Marrero J, Rho HS, Hu J, Hu S, Vera C, Bayron-Poueymiroy D, Rivera-Pacheco ZA, Ramos L, Torres-Castro C, Qian J, Bonaventura J, Boeke JD, Yap WY, Pino I, Eichinger DJ, Zhu H, Blackshaw S., Mol Cell Proteomics, 06/01/12, 11, 6, 10.1074/mcp.O111.016253, 22307071, PMC3433917
- A toolbox of immunoprecipitation-grade monoclonal antibodies to human transcription factors, Venkataraman A, Yang K, Irizarry J, Mackiewicz M, Mita P, Kuang Z, Xue L, Ghosh D, Liu S, Ramos P, Hu S, Bayron Kain D, Keegan S, Saul R, Colantonio S, Zhang H, Behn FP, Song G, Albino E, Asencio L, Ramos L, Lugo L, Morell G, Rivera J, Ruiz K, Almodovar R, Nazario L, Murphy K, Vargas I, Rivera-Pacheco ZA, Rosa C, Vargas M, McDade J, Clark BS, Yoo S, Khambadkone SG, de Melo J, Stevanovic M, Jiang L, Li Y, Yap WY, Jones B, Tandon A, Campbell E, Montelione GT, Anderson S, Myers RM, Boeke JD, Fenyö D, Whiteley G, Bader JS, Pino I, Eichinger DJ, Zhu H, Blackshaw S., Nat Methods, 05/01/18, 15, 5, 10.1038/nmeth.4632, 29638227, PMC6063793
Core Competencies
QMS implementation & management (ISO 9001/13485/27001), FDA/GMP/GCLP/GDPR compliance, Audit Management (Internal/External), CAPA Management, Supplier Quality, Computer System Validation (CSV), Equipment Qualification (IQ/OQ/PQ), Cross-functional leadership, Organizational Quality Strategy Development, Change Management, Budget Planning, Resource Allocation, Stakeholder/Executive Reporting (Quality Metrics), Conflict Resolution, Influencing without Authority, Operations Management, Facility & Construction Oversight, Environmental Health & Safety (EHS), Physical Security, Procurement & Supply Chain (Specialty Gases/Logistics), Systematic Troubleshooting, Business Continuity Planning, Agile Methodologies, Software Testing Life Cycle (STLC), UI Testing, Risk Management, Root Cause Analysis (RCA), Strategic Thinking, High Accountability, Customer-focused Mindset, Adaptability
Certification
ISO 27001 Lead Auditor Certification CPE:36 - Advisera Expert Solutions, LDT
Languages
English
Intermediate (B1)
B1
Spanish
Native
Native
Timeline
Quality Assurance Infrastructure Lead
CDI Laboratories Inc.
01.2024 - Current
Lead, Quality Assurance / Associate Operations Manager
CDI Labs
01.2023 - 01.2024
Quality Assurance / Associate Operations Manager
CDI-Labs
01.2021 - 01.2023
Quality Assurance / Associate Operations Manager / Animal Resource Scientist
CDI-Labs
01.2015 - 01.2021
Animal Resource Scientist / Associate Operations Manager
CDI-Labs
01.2009 - 01.2015
Bachelor of Science - General Agriculture Science, Minor in Biology
University of Puerto Rico