Summary
Overview
Work History
Education
Skills
Websites
Laboratory Techniques
Timeline
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Janelle Custodio

San Diego,CA

Summary

Detail-oriented and goal driven Laboratory and Quality Assurance professional with 5 years of experience in a CAP/CLIA accredited organization. Adept at driving team collaboration, showcasing effective leadership skills and dependability, ensuring quality and efficiency in all tasks.

Overview

5
5
years of professional experience

Work History

QUALITY SPECIALIST II

Epic Sciences
04.2024 - 02.2025
  • Responsible for maintaining Document Control Systems for Change Controls, Nonconformances, Standard Operating Procedures, and Periodic Reviews within the electronic Quality Management System (Trackwise, Salesforce)
  • Reviewed and approved 20+ batch records per month, by conducting data validation and verification to ensure accuracy and compliance with research protocols and regulatory requirements
  • Performed Lot Release and labeling of 30+ Clinical Laboratory reagents per month, by evaluation of CofAs and testing records
  • Monitored Quality Assurance logs on a monthly and quarterly basis, for tracking and trending of compliance metrics.
  • Supported routine internal audits and inspections of Clinical Laboratory and applicable testing to verify data integrity and quality
  • Managed SOP and Competency Training for internal and alliance laboratories (LabCorp in Geneva and Singapore), monitoring monthly and quarterly

LABORATORY SUPERVISOR

Epic Sciences
12.2021 - 04.2024
  • Interviewed, Oriented, and Trained over 20+ Laboratory Technician operators on several laboratory testing: Cell Deposition, Immunofluorescence Assay Staining, Light Microscopy, and CTC Classification
  • Mentored junior staff members to foster professional growth, skill development, and career advancement opportunities within the organization.
  • Oversight of training and competency for partner labs in Geneva for EU Region and Singapore for APAC Region for Biopharma and Academic Clinical Studies
  • Reviewed and Approved laboratory documentation of maintenance logs, assay forms, and patient sample reports daily
  • Coordinated lab operations by developing daily and weekly assignments for all Translational Research Laboratory Technicians
  • Developed and implemented new lab policies and procedures to improve workflow, ensure safety compliance, and maintain consistent research quality

LAB TECH 1&2, SENIOR LAB TECH

Epic Sciences
07.2020 - 12.2021
  • Accessioned BioPharma and Academic Patient blood samples from the US, Geneva, and Singapore into department specific Inventory systems (FreezerPro and QuickBase Application)
  • Performed blood sample processing: Cell Deposition, Immunofluorescent Staining, Microscopic Scanning, and CTC Analysis for 1000+ samples
  • Ensured accurate and detailed patient records in accordance with GLP regulations
  • Improved project and procedure outcomes, meticulously documenting development phases.

Education

Bachelor of Science - Chemistry

University of California, Irvine
06.2020

Skills

  • Proficient in Microsoft 365 Applications
  • Experience in managing laboratory technician reports
  • Experience in Documentation Control within Trackwise/Salesforce QMS
  • Skilled in Smartsheets for Project Management
  • Knowledgeable in QuickBase
  • Capable of assisting in Corodata off-Siting process
  • Effective in time management
  • Exceptional communication

Laboratory Techniques

  • Matsunami slide preparation on patient blood samples: red blood cell lysis, pellet resuspension, cell plating, application of reagents, proper instrument use, and slide storage.
  • Immunofluorescence assay staining primarily related to breast and prostate cancer, using the Biocare Medical IntelliPATH FLX.
  • Use and maintenance of light microscopy machines, Zeiss Pyxis, and Axio Scan. Z1 to scan glass microscope slides.
  • CTC Classification by analysis of DAPI, CK, and CD45/CD31 characteristics.

Timeline

QUALITY SPECIALIST II

Epic Sciences
04.2024 - 02.2025

LABORATORY SUPERVISOR

Epic Sciences
12.2021 - 04.2024

LAB TECH 1&2, SENIOR LAB TECH

Epic Sciences
07.2020 - 12.2021

Bachelor of Science - Chemistry

University of California, Irvine

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Janelle Custodio