Johanna Rodriguez Garay
Coral Springs
Summary
Results-driven R&D Laboratory Technician II with expertise in laboratory instrumentation and regulatory compliance. Enhances operational efficiency through project coordination and cross-functional collaboration. Manages calibration and inventory while ensuring compliance with FDA and DEA regulations.
Overview
18
18
years of professional experience
Work History
R&D Laboratory Technician II
Teva Pharmaceuticals
Weston
10.2008 - 08.2026
- Facilitated analytical testing and release of drug substances, intermediates, excipients, and finished pharmaceutical products to meet project timelines.
- Coordinate laboratory priorities and resources to ensure timely completion of research and development projects.
- Coordinated calibration, qualification, preventive maintenance, and repair of laboratory instrumentation to ensure accurate metrology support for analytical laboratories.
- Troubleshoot laboratory instrumentation issues and facilitate timely corrective actions to minimize operational downtime.
- Maintain laboratory documentation in compliance with cGMP, FDA, and Good Documentation Practices (GDP).
- Collaborate with Quality Assurance, Research & Development, Manufacturing, Engineering, and Regulatory Affairs to support project objectives
- Implemented continuous process improvements to enhance laboratory efficiency and ensure regulatory compliance.
- Monitor laboratory inventory and ensure adequate supplies of controlled substances and laboratory materials.
DEA Sample Coordinator
Teva Pharmaceuticals
Weston
10.2008 - 08.2026
- Received and dispensed DEA samples and standards for testing.
- Managed and maintained up-to-date DEA samples/reference standards/API inventory to support regulatory compliance.
- Assisted in compliant disposition of DEA samples and reference standards, ensuring final accountability of waste.
- Performed biennial inventory counts and maintained accurate records to uphold compliance with DEA regulations.
- Enter information in the DEA database/logbooks and perform daily environmental monitoring of DEA room.
- Work with DEA Compliance office to ensure compliance with all State and Federal Controlled Substance Regulations.
- Prepare and participate in DEA/cGMP/FDA/internal audit.
- Conform with and abide by all regulations, policies, work procedures, and instructions including cGMP, DEA and OSHA guidelines with regards to work practices and safety.
Education
Associate in Art - Business Administration
Broward College
Fort Lauderdale, FL08-2020
Skills
- LIMS/ELN systems
- Blue Mountain Regulatory Asset Manager (BM RAM)
- Laboratory Instrumentation
- Calibration Coordination
- Equipment Qualification
- Preventive Maintenance
- FDA Regulations
- DEA Compliance
- CGMP
- Documentation practices
- Regulatory Documentation
- Quality Systems
- ANDA Support
- Inventory Management
- Project Coordination
- Analytical Problem Solving
- Process Improvement
- Microsoft Office Suite
- Documentation Management
- Collaborative teamwork
- Vendor Management
- Organization
- Time Management
- Effective Communication
- Time Management
Languages
- Fluent in English
- Fluent in Spanish
Leadership Experience
Teva Pharmaceuticals, Weston, FL 10/2008- 08/2026
- DEA Sample Coordinator
- R&D Laboratory Technician II
Recognized through performance evaluations for consistently exceeding expectations in laboratory operations and regulatory compliance. Trusted resource for coordinating DEA-controlled substances and ensuring adherence to strict pharmaceutical industry regulations., Supported successful regulatory submissions through accurate documentation and laboratory coordination. Played an integral role in maintaining operational readiness of analytical laboratory instrumentation.
Timeline
R&D Laboratory Technician II
Teva Pharmaceuticals
10.2008 - 08.2026
DEA Sample Coordinator
Teva Pharmaceuticals
10.2008 - 08.2026
Associate in Art - Business Administration
Broward College