Detail-oriented Quality Control Analyst well-versed in qualitative and quantitative analysis techniques. Demonstrated knowledge of scientific principles and clinical analysis. Strong background in collecting and analyzing quality measures and making recommendations for process and quality improvements. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Hi, I’m
LETICIA LUGO
Salt Lake City,UT
Summary
Overview
10
years of professional experience
Work History
Pyxant Laboratories
QC Specialist
03.2022 - Current
Job overview
- Assists co-workers and internal customers with interpreting regulatory requirements (GLPs), SOP requirements, and other guidance documents, as applicable.
- Reviews data to ensure quality standards are met and verify compliance with applicable SOP and regulatory requirements.
- Performs regularly scheduled audits of departmental systems and supporting data, as applicable, to ensure proper documentation and maintenance (training files, client SOP reading lists, logbooks, etc.).
- Review reagent and pooled matrix documentation for adherence to SOPs, GLP guidelines, and established laboratory policies.
- Review QC data tables of samples analyzed for accuracy and consistency before sending them to the client.
- Review sample receipt, stock/matrix stability, PSAE, sample analysis, and validation study run folders for adherence to SOPs, GLP guidelines, and established laboratory policies.
- Participates in quality improvement opportunities and harmonization efforts to promote best practices.
- Assist QC Lead in training QC team members and project team members on QC processes, laboratory procedures, GLP guidelines, lab policies & basic laboratory science as needed.
- Interacts with operations personnel, scientific personnel, QA, and departmental management to address critical errors.
- Promotes quality and regulatory compliance within the department by working with operations and scientific staff to resolve service/quality issues, serving on a committee, and assisting in developing training programs for new employees.
Teva Pharmaceuticals
Chemist
08.2018 - 03.2022
Job overview
- Proficiently analyze and troubleshoot equipment such as HPLC, GC, FTIR, and INSTRON.
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Compliance with all Good Laboratory Practices/Good Manufacturing Practices and safety requirements.
- Ensure compliance with the safe handling and disposal of control substances such as testosterone gels.
- Maintaining and monitoring the use of control substances such as testosterone.
- Interpret collected data to document findings in technical papers and reports.
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
Ultradent Products, Inc
Chemist
07.2015 - 08.2018
Job overview
- Demonstrated proficiency in operating and troubleshooting equipment such as HPLC, IC, UV/VIS, GC, and FTIR.
- Thoroughly conducted and documented raw materials, in-process, and final product analysis.
- Performed maintenance, preventative maintenance, and qualification of the instrumentation within their division of the laboratory in coordination with the quality group.
- Responsible for the accurate results, testing, reporting, and on-time delivery of samples within their division.
Edwards Lifesciences
Technologist
07.2013 - 07.2015
Job overview
- Participated in designing and developing new catheter products.
- Enhanced manufacturing processes by developing new fixtures to optimize the workflow of the production lines.
- Conducted a thorough investigation of the Equipment Non-Conformance Report (ENCR).
- Operated and qualified equipment used on different catheter production lines.
- Performed an Out of Tolerance investigation to determine the impact on the affected product.
- Trained operators in new equipment or fixture.
- Proficiently scheduled and performed preventive maintenance and calibration on equipment.
- Efficiently executed equipment validations such as the Inspection Qualification/Operation Qualification (IQ/OQ) based on the critical assessment level of the manufacturing line.
- Assisted with setting up new lines from diversified products while ensuring compliance with company standards.
Education
Western Governors UniversityMS
Master of Science from DATA ANALYTICS
09.2021
University Overview
Udacity
Nanodegree in Data Analytics
Graduated August - 2019
SAS 9.4 Base Programming Certification.
Registration number 389578942
Skills
- Managing Risk
- Operational Process Flows
- Support Audits
- Database Maintenance
- Write Technical Reports
- Production Monitoring and Assessment
- Monitor Quality Control
- Corrective Actions
- Product Specifications
- Equipment Testing and Calibration
Timeline
QC Specialist
Pyxant Laboratories
03.2022 - Current
Chemist
Teva Pharmaceuticals
08.2018 - 03.2022
Chemist
Ultradent Products, Inc
07.2015 - 08.2018
Technologist
Edwards Lifesciences
07.2013 - 07.2015
Western Governors UniversityMS
Master of Science from DATA ANALYTICS
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