Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Timeline
Generic

ALEXANDRA TEJADA-STROP

Atlanta area

Summary

Regulatory Affairs and Quality Assurance professional with over 10 years of experience in regulatory submissions and quality systems in biotech and public health. Skilled in coordinating documentation, managing regulatory filings, and ensuring compliance throughout the product lifecycle. Strong communicator and collaborator, fluent in Spanish.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Safety Officer & Laboratory Quality Specialist

Centers for Disease Control and Prevention - Division of Viral Hepatitis
12.2021 - Current
  • Manage regulatory documentation and quality assurance in a diagnostic setting.
  • Conduct regulatory impact assessments, support internal audits, and prepare data for stakeholders, including federal bodies.
  • Improved regulatory response time by 30% and ensured full QMS compliance for better inspection readiness.

Biologist

Biologist - Division of Viral Hepatitis Reference laboratory
11.2016 - 12.2021
  • Supported documentation and quality control for CLIA diagnostic projects.
  • Engaged in data analysis, drafted SOPs, and compiled technical summaries for evaluations. Ensured sample traceability and coordinated change control with QA.
  • Reduced documentation errors by 25% and enhanced data support for compliance reviews and product assessments.

ORISE Fellow

ORISE Fellow - Division of Viral Hepatitis Assay Development
09.2012 - 11.2016
  • Assisted with regulatory and scientific data for global health studies, including Class II diagnostic validations.
  • Participated in international projects on pre-analytical sample handling, authored technical reports, and reviewed regulatory policy literature.
  • Contributed to submission readiness for hepatitis diagnostics and aligned with international regulatory trends and risk-based strategies.

Education

Master of Science - Biology

Georgia State University
01.2012

Bachelor of Science - Biology

Georgia State University
01.2010

Skills

  • OSHA, NFPA, ANSI, NEC Compliance
  • EHS Program Leadership & Strategic Implementation
  • Risk Assessment & Hazard Mitigation
  • Root Cause Analysis & Corrective Action Planning
  • FDA QSR, CLIA, ISO 13485 Compliance
  • Internal & External Audits/Regulatory Inspections
  • Diagnostic Tools: Vitros 3600, Architect i2000, PCR, ELISA, Sequencing
  • KPI Development & Compliance Reporting
  • Environmental Health & Safety Certification
  • Cross-Functional Team Leadership & Mentoring
  • Fluent in Spanish
  • Safety training
  • Workplace safety
  • Hazard identification
  • Occupational safety

Accomplishments

  • Planned and implemented the company-wide rollout of a proactive safety and health target program, partnering with field management and supervisory staff and effectively reduced overall accidents by [Number]%.
  • Identified hazardous chemicals used in the [name of school district], provided alternative product suggestions and reduced overall classroom absentee rates for asthmatic children by [Number]%.
  • Received [title of award] for [reason].
  • Trained staff members via Skype in the proper methods to remove hazardous waste, cutting back on travel costs by [Number]% and saving $[Number] annually.
  • Researched and identified a new glove manufacturer who provided a quality product at [Number]% the previous cost, resulting in a savings of $[Number].
  • Streamlined the communications process for incident reporting which resulted in [Number]% improvement in positive outcomes.
  • Documented and resolved [Issue] which led to [Results].
  • Achieved [Result] by introducing [Software] for [Type] tasks.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Achieved [Result] through effectively helping with [Task].
  • Achieved [Result] by completing [Task] with accuracy and efficiency.

Certification

  • CSP - Certified Safety Professional
  • CHHM - Certified Hazardous Materials Manager

Languages

Spanish
Native or Bilingual
English
Native or Bilingual

Timeline

Safety Officer & Laboratory Quality Specialist

Centers for Disease Control and Prevention - Division of Viral Hepatitis
12.2021 - Current

Biologist

Biologist - Division of Viral Hepatitis Reference laboratory
11.2016 - 12.2021

ORISE Fellow

ORISE Fellow - Division of Viral Hepatitis Assay Development
09.2012 - 11.2016

Bachelor of Science - Biology

Georgia State University

Master of Science - Biology

Georgia State University
ALEXANDRA TEJADA-STROP