Summary
Overview
Work History
Education
Skills
Professional Development
Awards
References
Timeline
Generic

Yelitza Figueroa Olivieri

Juana Díaz

Summary

Inclusive and high credibility Quality Control Laboratory Analyst; sustainable & results oriented as well as highly effective driving and adapting to change. Over twelve (15) years of experience and exposure to FDA Protocols & Audits, Laboratory data review, TOW’s (Transfer of Work) & NPI’s (New Product Introduction), Test & Protocols Development & Lean Manufacturing. Establish EHS (Environmental health & Safety) and Quality as core values on all teams and assignments. Strong capacity of energize teams and align resources with Business needs. Strong drive to help others grow professionally, coupled with a personal conviction of life-long learning. Motivated Validation Scientis with a career spent providing accurate reporting of test results. A diligent employee tasked with validation documenting and extensive record keeping. Ready for a new validation role in the pharmaceutical industry. Dependable professional willing to shoulder various responsibilities, including auditing and testing for the pahrmaceutical/ medical divice sector. A smart Validation Engineer known for having exceptional math, communication and decision- making talents. Committed job seeker with a history of meeting company needs with consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Organized and motivated employee eager to apply time management and organizational skills in various environments. Seeking entry-level opportunities to expand skills while facilitating company growth.

Overview

23
23
years of professional experience

Work History

Validation Scientist

Orvis V
Gurabo, Puerto Rico
04.2023 - Current
  • Developed test protocols, plans, scripts and reports for system validation activities.
  • Created and maintained documentation related to validation activities such as traceability matrices and risk analysis documents.
  • Executed regression testing to verify that changes made do not impact existing functionality of a product or system.
  • Documented results of all validation tests performed for future reference and audit purposes.
  • Prepared summary reports highlighting key findings from the validation process.
  • Collaborated with developers in troubleshooting issues identified during the validation process.
  • Ensured that all systems comply with applicable regulatory guidelines such as FDA 21 CFR Part 11.
  • Provided training on proper usage of validated systems according to established procedures.
  • Documented entire validation process and recorded all changes.
  • Provided continuous process improvement and preventive and corrective actions to facilitate operational efficiency.
  • Communicated effectively with customers and contractors to facilitate business operations.
  • Developed and executed validation protocols for process and equipment qualification.
  • Provided technical support in the development of product specifications based on customer requirements.
  • Analyzed data from validation studies for trends or anomalies that may require further investigation.
  • Documented validations for new products or changes to existing products and processes following FDA regulations.
  • Monitored production areas during validation runs ensuring safety regulations are adhered to at all times.
  • Provided training on proper methods for executing validations throughout the organization.
  • Facilitated regular meetings with stakeholders regarding progress towards completion of validations.
  • Collaborated with other departments on various initiatives related to product development and launch activities.
  • Scheduled validation testing with different departments and managers.
  • Collaborated with production team members to help team create and deliver high quality, cutting-edge products.
  • Developed protocols for validating Validation Scientist products against internal and industry standards.
  • Collected samples to validate against parameters using various approved tests.
  • Maintained and calibrated testing equipment to consistently produce reliable results.
  • Developed protocols for validating [Type] products against internal and industry standards

Bakery Manager

Bread and Butter
05.2022 - 11.2022
  • In charge of coordinating production, buying inventory, and managing inventory
  • Supervising inventory, coordinating, and planning itineraries of work of each area and their schedule
  • We are improving and maintaining the service of the client.

Administrative Assistant

Nortol Environmental and Occupational Safety
05.2020 - 05.2022
  • Supervising and leading the teamwork, coordinating visits and projects, nominee employees
  • Supervising over 10 employees
  • Coordinating visits and daily projects
  • Coordinating agendas and daily work of employees
  • Give out the nominee of employees
  • Give out a registry of daily spends and refunds to employees
  • Tabling and generating reports with daily work
  • Revising the generated data of the inspections and projects
  • Sending final reports of clients through email
  • Maintenance with clients and providers of service.

Quality Control Laboratory Analyst

Janssen Ortho LLC
Gurabo
07.2011 - 05.2020
  • Responsible of organize and analyze finished products using different equipment’s (pH meter, viscosity, NIR, HPLC, GC, IR, UV, UPLC H class), as required
  • Prepare materials and equipment to be use in the laboratory test and calibrate the instruments, assist in the adjustment of initial troubleshooting of the instrument
  • Using of procedure to comply with product specifications
  • 0 HE Investigation identified from 2015 to 2018
  • No accidents or lost time related to Policy/Procedure Violations
  • 0 critical observations during EMA and FDA audits were reported
  • Support during laboratory investigations of nonconform products
  • Completed the Medical Surveillance
  • Completed the Compliance wire trainings on time
  • Owned Housekeeping (6’s) in Cell 3
  • Completed Good Save Requirements every year
  • Sustained Smart QC activities documented to report the Earned Hours more 30 hrs/week
  • Supported the analysis on Empower system, the eLims system and equipment troubleshooting
  • Qualified Analysis on most test methods of Cell 1 & 3
  • Achieved Analysis an efficiency of 94% and an average efficiency of 100% on Smart QC tool on 2018
  • Supported Business OTD Metric 95% by sustained the batch analysis on time to support and maintain the product cycle times and new targets for Xarelto and Prezista, also supported on Remicade raw data review to release the results within cycle time
  • With her support Cell Complied with the metric of 60 lots approval each week
  • Maintained the efficiency of 103% to assure earned hours increase.

Quality Control Laboratory Analyst

Baxter
Guayama
02.2006 - 07.2011
  • Responsible for Performance Quality Control Analysis of Raw Materials, In-process samples, retain samples, Stability samples and Finished Goods in accordance to Baxter Standard Operating procedures in order to support production processes
  • Prepared and submitted accurate and timely analysis reports using LIMS
  • Worked in Wet Chemistry and USP/EP/JP compendia techniques
  • Prepared and standardized Actions from Root Cause Analysis performed
  • Created, monitored & sustained lab metrics
  • Trained lab personnel new lab personnel.

General & Organic Tutor

Pontifical Catholic University
Ponce
08.2005 - 12.2005
  • Responsible for helping to improve student performance, based on the fundamentals of chemistry, supervise the laboratory, also ensure or facilitate their integration into their group, class and University dynamics
  • Helped about 10 students to better understand and passed Chemistry Classes
  • Coached students on upcoming situations during University Life
  • Supervised Laboratory to ensure proper preparation to perform tasks
  • Ensure no accidents or near misses during tutorials or Lab Activities
  • Monitored the students, to detect difficulties in their teaching-learning process, and developed appropriate educational responses.

Recreational Leader

Sports & Recreational Dept.
Villalba
05.2001 - 01.2002
  • Responsible for integrating sports and recreation into children's development for their future
  • Planned Daily Schedule
  • Responsible for periodic attendance and actions on absenteeism
  • Distributed and maintained control of equipment and supplies
  • Responsible for opening, closing and securing indoor and outdoor facilities while conducting recreational activities to ensure safety on participants
  • Trained & Supervised volunteers
  • Organized groups according to age interests and coordinate community relations activities to promote recreation and cultural programs.

Education

Bachelor’s Degree in Chemistry -

PUCPR- Ponce PR
12.2005

Skills

  • Laboratory Information Systems
  • SAP
  • ELims
  • EMPOWER3
  • Minitap
  • SMART QC
  • Track-wise system
  • Continuous Improvement
  • Lean Manufacturing
  • NPI’s Validation
  • Troubleshooting of laboratory equipment’s (KF, GC, TLC, HPLC, UPLC H Class, Dissolution Apparatus, PH meter, UV Agilent)
  • Investigations of Nonconformance products
  • Validation Protocols
  • CAPA
  • Root cause analysis
  • Standard Operating Procedures
  • Good Manufacturing Practices
  • Effective Communication
  • Math Skills
  • Data Integrity
  • Testing Protocols
  • Process Validation
  • Regulatory Guidelines
  • FDA Regulations
  • Problem-Solving
  • Critical Thinking
  • Audit Processes
  • Teamwork and Collaboration
  • Problem-Solving Abilities
  • Multitasking
  • Time Management
  • Adaptability
  • Interpersonal Communication
  • Problem-Solving Aptitude
  • Active Listening
  • Self Motivation
  • Attention to Detail
  • Team Building
  • Analytical Thinking
  • Validation Testing
  • Decision-Making
  • Excellent Communication
  • Analytical Skills
  • Data Integrity Validation
  • Reliability
  • Report Writing
  • Organizational Skills
  • Relationship Building
  • Team Collaboration
  • Goal Setting
  • Adaptability and Flexibility

Professional Development

  • Active PR Chemist License
  • Yellow Belt Certified
  • Lean 5s Training
  • SAP
  • Laboratory Analysis Techniques certification by Johnsson and Johnsson company
  • Training of trainers

Awards

  • Weekend Laboratory Leader since 2016
  • Leadership Encore recognition
  • Deliver Encore recognition

References

Furnished upon request

Timeline

Validation Scientist

Orvis V
04.2023 - Current

Bakery Manager

Bread and Butter
05.2022 - 11.2022

Administrative Assistant

Nortol Environmental and Occupational Safety
05.2020 - 05.2022

Quality Control Laboratory Analyst

Janssen Ortho LLC
07.2011 - 05.2020

Quality Control Laboratory Analyst

Baxter
02.2006 - 07.2011

General & Organic Tutor

Pontifical Catholic University
08.2005 - 12.2005

Recreational Leader

Sports & Recreational Dept.
05.2001 - 01.2002

Bachelor’s Degree in Chemistry -

PUCPR- Ponce PR

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Yelitza Figueroa Olivieri