Ramya Reddy Mekala
Denton,Texas
Summary
Detail-oriented biomedical engineering graduate with expertise in regulatory compliance and product validation. Completed projects and internships focused on ISO and FDA quality systems, design verification, and data auditing. Proficient in Good Documentation Practices, risk analysis, and quality inspections in biomedical and pharmaceutical settings. Ready to leverage knowledge of quality control processes and regulatory standards to enhance product safety in a healthcare organization.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist
Synergy Bioscience
Dallas, TX
06.2024 - 05.2025
- Performed comprehensive laboratory data verification and audits to ensure compliance with GMP, GLP, and internal SOPs.
- Conducted reviews of raw data, analytical reports, and batch records for accuracy and regulatory compliance.
- Audited analytical data following FDA and EMA regulatory standards.
- Processed QA documents by scanning, printing, and filing according to documentation control procedures.
- Reviewed and approved Certificates of Analysis (CofA) and Analytical Result Forms (ARFs).
- Reviewed Stability Study Protocols and Reports in line with ICH guidelines.
- Led internal audits of laboratory facilities in alignment with QMS standards.
- Adhered to Good Documentation Practices (GDP) in all QA recordkeeping activities.
- Collaborated with QC and analytical teams to resolve documentation discrepancies.
- Prepared for regulatory inspections by organizing documentation and supporting audit readiness.
Quality Assurance Specialist
Phillips-Medisize
Bangalore, KA
08.2022 - 05.2023
- Performed comprehensive laboratory data verification and audits to ensure compliance with GMP, GLP, and internal SOPs.
- Conducted reviews of raw data, analytical reports, and batch records for accuracy and regulatory compliance.
- Audited analytical data following FDA and EMA regulatory standards.
- Processed QA documents by scanning, printing, and filing according to documentation control procedures.
- Reviewed and approved Certificates of Analysis (CofA) and Analytical Result Forms (ARFs).
- Reviewed Stability Study Protocols and Reports in line with ICH guidelines.
- Led internal audits of laboratory facilities in alignment with QMS standards.
- Adhered to Good Documentation Practices (GDP) in all QA recordkeeping activities.
- Collaborated with QC and analytical teams to resolve documentation discrepancies.
- Prepared for regulatory inspections by organizing documentation and supporting audit readiness.
Education
Master of Science - Biomedical Engineering
University of North Texas
Denton, TX05.2025
Bachelor of Engineering - Biotechnology
Koneru Lakshmaiah University
Guntur, India05.2022
Skills
- Quality assurance and compliance: GMP, GLP, GDP, GxP, ICH, FDA, EMA regulations, ISO 13485, CAPA, QMS, internal audits, documentation and review: SOPs, CofA/ARF review, stability protocols, DHF, change control, risk management, tools and software: Python, R, SAS, statistical modeling, bioinformatics, machine learning, technical testing: environmental swab testing, device calibration, analytical validation, communication: cross-functional collaboration, training support, technical reporting
Projects
Biosristi Hyderabad, India
In-Silico Biology Intern
Oct 2021 – Nov 2021
· Evaluated data integrity and model validation in ligand docking simulations to support preclinical QA standards in drug discovery.
· Applied statistical models for analyzing biological pathway data, ensuring reproducibility and consistency in simulation outputs.
· Maintained Good Documentation Practices (GDP) and created technical reports for internal QA audit trails.
Smart Dual Drug-Eluting Stent Development
· Implemented risk management processes aligned with ISO 14971 and FDA QSRs for combination product development.
· Drafted and reviewed Design History Files (DHF) and Design Verification Protocols, ensuring compliance with regulatory design controls.
· Conducted analytical testing to verify drug-release rates and validated biocompatibility following quality and safety standards.
Pneumatic Soft Robotic Gripper
· Developed and executed test protocolsfor real-time sensor feedback and control system functionality to validate device reliability.
· Recorded and analyzed lab data following QA procedures, supporting corrective actions for system calibration and process control.
· Contributed to root cause analysis (RCA) for performance inconsistencies and recommended quality improvements.
Certification
- Sigma Green Belt, Yellow Belt, White Belt
- Biomedical Visualization (Coursera)
- Clinical Data Management, ICH-GCP
- Python Programming, SAS Certification
- Biomedical Instrumentation & Compliance (USA, 2024)
Accomplishments
Distinction in Spoken English Trinity College London
• Grade 6 Completed 5+ industry certifications in biomedical tools and clinical QA system
Timeline
Quality Assurance Specialist
Synergy Bioscience
06.2024 - 05.2025
Quality Assurance Specialist
Phillips-Medisize
08.2022 - 05.2023
Master of Science - Biomedical Engineering
University of North Texas
Bachelor of Engineering - Biotechnology
Koneru Lakshmaiah University
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