Summary
Overview
Work History
Education
Skills
Certification
Timeline
Accomplishments
Affiliations
Awards
Luz A Navarro

Luz A Navarro

Quality Specialist
Ocala,FL

Summary

Experienced staff specialist with a proven track record in supporting operational and process improvement initiatives. Utilizes strong strategy and organizational skills to enhance team performance and drive results. Known for fostering collaboration, adapting to changing needs, and achieving goals effectively. Certified Quality Auditor (CQA) with valuable experience in optimizing team workflows and implementing process improvements to ensure consistent results.

Overview

24
24
years of professional experience
1
1
Certificate

Work History

Staff Specialist, Quality

Thermo Fisher Scientific
11.2021 - 05.2025
  • Managed the IT QMS Internal Audit Program and the Supplier Qualification Program. Improved as of 100% of on-time audits.
  • Reviewed and approved computer system validation, infrastructure qualification, and change control activities (planning, documentation, testing, reports) for regulated Global IT systems.
  • Developed and implemented training programs to enhance staff skills and performance.
  • Collaborated with peers in designing and maintaining Quality Systems for deviations, CAPA, Training, and Change Management programs.
  • Streamlined operational processes, resulting in improved efficiency across teams.
  • Strong experience in risk assessments, particularly as it relates to deviations, CAPA, and Change Controls.
  • Collaborated with peers in both IT and the business groups to support regulatory and client audits.
  • Led/actively participated in the IT vendor/supplier qualification and management program.
  • Assisted with the authoring and document management of Corporate IT Standard Operating Procedures (SOPs).
  • Assisted with the management of the training program and management for Global IT staff.
  • Identified and delivered Quality System metrics and report results to management.
  • Analyzed workflow trends and identified areas for process improvement.
  • Coordinated project timelines and deliverables to meet organizational goals effectively.

Engineer II, QA

Thermo Fisher Scientific
10.2018 - 11.2021
  • Provided support in validation strategy meetings related to facility, utility, automation, equipment and QC Lab operation activities.
  • Led engineering projects, ensuring adherence to design specifications and regulatory standards.
  • Provided QA support for process validation activities.
  • Provided comments for proposed protocols
  • Developed innovative solutions to optimize system performance and enhance efficiency.
  • Provided QA support for change controls
  • Reviewed for execution approval of change control per change control SOP and Client agreements
  • Collaborated with cross-functional teams to drive project timelines and deliverables effectively.
  • Provided QA support, and guidance on exceptions related to facility, utility, equipment and process activities
  • Responsible for the monitoring and reporting of QA Metrics
  • Supported QA Compliance activities as needed or assigned by the Quality Director

Quality Manager & EHS Coordinator

Cascade Designs Inc.
08.2017 - 10.2018
  • Managed the Quality Assurance and Environmental, Health & Safety functions of the QA and Safety Division
  • Developed, implemented and managed QA, product liability and employee safety program
  • Led cross-functional teams in root cause analysis to identify and resolve quality issues effectively.
  • Managed the risk management process at Cascade Designs Nevada (CDN)
  • Analyzed customer feedback and inspection data to drive strategic improvements in product design and functionality.
  • Ensure procedures and actions are in place to achieve excellent quality and champion continuous improvement
  • Supported Product Development by actively participating in the development of Product Development processes and ensuring
  • Managed effectively the Environmental, Health & Safety program and safety incidents resolution
  • OSHA 300 & 300A Log management
  • Conducted training sessions for staff on quality standards, fostering a culture of continuous improvement.

Quality Engineer/Scientist II, QC

Thermo Fisher Scientific
06.2016 - 08.2017
  • Performed the corresponding analysis of melting point (MP), refractive index (RI), pH, identification and appearance
  • Led quality assurance initiatives, ensuring compliance with industry standards and regulations.
  • Evaluated receipts of chemicals and precious metals as they are received into the inventory database
  • Validated and calibrated Laboratory Equipment and implemented new analytical process methods
  • Developed and implemented testing protocols to enhance product reliability and performance.
  • Ensured product quality throughout every stage of operations
  • Inspection of the products when received and perform follow up as appropriate when products are rejected
  • Ensured that the inventory meet company quality standards and visually inspected products received into quality control status
  • Examined chemical product reports and file the appropriate paperwork
  • Completed daily certifications of analysis ratings for all receiving
  • Generated the SOPs related to the operational and quality areas, and participated in quality control cycle counts
  • Address customer complaints in a timely manner and assisted services with inquiries of product quality
  • Review and approve Certificates of Analysis and/or Certificates of Test

Quality Assurance Associate II, Customer Compliance

Baxter Healthcare
11.2011 - 05.2016
  • Monitored multiple databases to keep on track and coordinated all activities to complete the complaints investigation
  • Non-conformance investigations and Corrective Action Preventive Action (CAPA) handling
  • Conducted thorough inspections and audits to ensure compliance with industry standards.
  • Evaluated for Field Alert Report (FAR) submissions
  • Provided regulatory guidance and support for medical device submissions, ensuring compliance with Regulatory legislation and guidelines, resulting in timely approvals and maintaining product registrations
  • New Drug Applications (NDA), ANDA and Supplements handling
  • I supported the medical device software integration process
  • Generated Risk Assessment for Distributed Product and conducted and Assisted the Internal Audit Program and conduct Internal Audits
  • Batch Record Review (MBR) and Retained Sample evaluations, complaint investigations to assure compliance of release lots
  • Established and follow-up actions of complaint investigations and implementation of corrective actions
  • Provided training to laboratory and manufacturing staff on GLP/GMP regulations, best practices and internal requirements

Stability Coordinator/Release Specialist

Baxter Healthcare
03.2006 - 10.2011
  • Coordinated the site stability program to assure lots are tested and reports are issued in accordance with stability protocol
  • Performed stability report and analyzed stability data for significant trend
  • Assured stability incubators are working in optimal conditions and within operating range
  • Support pharmaceutical QC, method validations, analytical methods, regulatory interactions, cleaning method development
  • Generated Company Site Master File (SMF) and the Annual Product Review (APR) - Best Practice as part of cGMP Audit
  • Annual Good Manufacturing Practices (GMP) training and the GMP training to new hires
  • Revised and maintained procedures under ISO/FDA standard regulatory compliance
  • Maintained the Stability Program of the anesthetic products.
  • Analyzed workflow processes to identify bottlenecks and recommended actionable solutions for improvement.
  • Qualified the REES CENTRON Monitoring System Upgrade per Stability Incubators monitoring in compliance with Life Cycle requirements
  • Development and implementation of quality systems to improve change control process of drug products/clinical trials programs
  • Review and approve product-related documentation, including raw material release, batch records, quality control test results and resolve discrepancies, as needed
  • Coordinated cross-functional teams to streamline project execution and enhance operational efficiency.

Chemistry Organic/Laboratory Professor

Universidad Interamericana de Puerto Rico
01.2010 - 05.2010
  • Organic Chemistry & Laboratory Professor
  • Organized and prepared educational material for classes according to curriculum
  • Evaluated Exams and Laboratory Reports as part of the Natural Science & Technology Department
  • Developed and delivered engaging curriculum across multiple disciplines to enhance student learning experiences.

Quality Control Inspector

Baxter Healthcare
03.2004 - 03.2006
  • Inspected components and raw materials used in GMP production to ensure that all materials met specifications
  • Inspected the production line of anesthetic products fill and pack area to ensure the quality of the process
  • Coordinated protocols and gave support to validation area
  • Completed precise measurements using special tools

Environmental Laboratory Technician

Baxter Healthcare
02.2001 - 02.2004
  • Performed laboratory analysis such as: TSS, SS, GC, pH, Metal in Atomic Absorption & ICP, Oil and Grease, Fluoride, Wet Chem, Gravimetric analysis, Acid/Base titrations, UV-Vis, FT-IR, Karl Fisher, Titration, Densimeter, Viscometer, Refractometer, Extractions/clean-up methods, Standardization, Standard (Stock & working) preparation
  • Performed System Suitability verification; LIMS handling; EPA Standard Methods handling
  • Calibrated Laboratory Equipment; Verified data integrity and accuracy
  • Validation Master Plan (VMP) handling
  • Conducted complex chemical analyses to ensure compliance with environmental regulations.

Education

Bachelor of Science - Chemistry

Pontificia Universidad Católica De Puerto Rico, Puerto Rico
05.2009

Bachelor of Science - Chemical Technology

Universidad Interamericana De Puerto Rico, Puerto Rico
05.1997

Skills

  • Results-oriented
  • Customer satisfaction
  • Critical thinking
  • Quality Inspection
  • Team leadership
  • Sense of urgency
  • Problem-solving
  • Computer proficient
  • Optimism and a can-do attitude
  • Passionate about challenges and learning new things
  • Team collaboration
  • Stakeholder engagement
  • Coaching and mentoring
  • Analytical thinking
  • Continuous improvement

Certification

  • Certified Quality Auditor (CQA) by ASQ
  • Safety & Health Practitioner Certified
  • ASQ academy of Pharmaceutical cGMP Professional
  • ASQ Certified Quality Improvement Associate Academy
  • BEC 21 CFR 211- Training
  • Stability Programs for the Regulated Industries
  • OSHA 30- Hours General Industry Outreach Program, Hazardous Material Technician Level 24hr
  • GAMP5, Annex 11/Part 11 Basic Principles (ISPE) Academy
  • ISO 9001:2015 Internal Auditor Training

Timeline

Staff Specialist, Quality - Thermo Fisher Scientific
11.2021 - 05.2025
Engineer II, QA - Thermo Fisher Scientific
10.2018 - 11.2021
Quality Manager & EHS Coordinator - Cascade Designs Inc.
08.2017 - 10.2018
Quality Engineer/Scientist II, QC - Thermo Fisher Scientific
06.2016 - 08.2017
Quality Assurance Associate II, Customer Compliance - Baxter Healthcare
11.2011 - 05.2016
Chemistry Organic/Laboratory Professor - Universidad Interamericana de Puerto Rico
01.2010 - 05.2010
Stability Coordinator/Release Specialist - Baxter Healthcare
03.2006 - 10.2011
Quality Control Inspector - Baxter Healthcare
03.2004 - 03.2006
Environmental Laboratory Technician - Baxter Healthcare
02.2001 - 02.2004
Pontificia Universidad Católica De Puerto Rico - Bachelor of Science, Chemistry
Universidad Interamericana De Puerto Rico - Bachelor of Science, Chemical Technology

Accomplishments

  • Achieved the Internal Audit Program innovation by introducing the Audit Module in the electronic QMS Software.
  • Achieved the Supplier Qualification Program improvement by completing 100% of on-time of supplier audits with accuracy and efficiency.

Affiliations

  • Member of American Society for Quality (ASQ)
  • Member of Colegio de Químicos de Puerto Rico (CQPR)

Awards

  • Jury of the Competency of You Be the Chemist Challenge (YBTC) 2016 sponsored by Dow Agro Science and Chemical Educational Foundation (CEF)
  • Delegated of Academy of the Chemist Professional Organization of the Chemist College of Puerto Rico, Recognition by Baxter Global Service for 75 hours of Volunteerism
  • Recognition as Baxter Healthcare 2009 Symbol Employee
  • Recognition in the College Board National Hispanic Scholar Award Competition for outstanding Hispanic students, where obtained an Honorific Award for competing and obtaining a highest score

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Luz A NavarroQuality Specialist