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Gbemisola ojekanmi

@gbemisolaojekanmi

I am a quality-focused clinical research and QA professional.

United States
Message

What I'm looking for

I seek a senior clinical quality or QA role where I can lead audits, ensure inspection readiness, improve quality systems, mentor teams, and apply regulatory science to safeguard patient safety and product integrity.

I am a quality-focused clinical research and quality assurance professional with over 10 years' experience across clinical research, aseptic manufacturing, and QA. I am pursuing an MSc in Regulatory Science to deepen expertise in global compliance, regulatory submissions, and quality strategy.

I have implemented and maintained quality systems, conducted site and GCP/ICH audits, managed CAPAs, and supported inspection readiness for regulatory authority engagements. I drive batch disposition and deviation investigations, contribute to SOP development and training, mentor colleagues, and deliver process improvements that protect patient safety and data integrity.

Experience

Work history, roles, and key accomplishments

AF

Clinical Research Associate

ARSC Federal

Nov 2023 - May 2025 (1 year 6 months)

Performed clinical monitoring and site management for assigned studies, conducting QV/SIV/MV/COV and 100% source document verification to ensure GCP/ICH compliance; supported FDA/MHRA inspection readiness and led audits and CAPA implementation.

Catalent Pharma Solutions logoCS

Quality Assurance Specialist

Catalent Pharma Solutions

May 2021 - Nov 2023 (2 years 6 months)

Provided QA support for GMP documentation and batch disposition, tracked and reported quality metrics, led deviation investigations and CAPAs, and collaborated with manufacturing to ensure timely lot release and compliance.

PI

Aseptic Filling Technician

Pharmaceutics International Inc.

Dec 2019 - May 2021 (1 year 5 months)

Performed aseptic compounding, filtration, filling and capping in ISO 5 environment per SOPs and GMP, served as SME for vial capping and filter integrity testing, and maintained cleanroom compliance and equipment calibration.

Education

Degrees, certifications, and relevant coursework

University of Maryland, Baltimore logoUB

University of Maryland, Baltimore

Master of Science, Regulatory Science

2024 -

Pursuing a Master of Science in Regulatory Science with coursework focused on regulatory submissions, global compliance, and quality strategy.

University of Lagos logoUL

University of Lagos

Bachelor of Science, Business Administration

2010 - 2015

Completed a Bachelor of Science in Business Administration at the University of Lagos from 2010 to 2015.

TI

The Biotechnical Institute of Maryland, Inc.

Certificate Program, Laboratory Science

2019 -

Completed the BioSTART to Laboratory Associates program focusing on laboratory techniques and entry-level biotechnology skills in 2019.

Tech stack

Software and tools used professionally

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Gbemisola ojekanmi - Clinical Research Associate - ARSC Federal | Himalayas