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Ashley Bragg

@ashleybragg

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Quality Assurance Specialist with expertise in regulatory compliance.

United States

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What I'm looking for

I am looking for a role that fosters growth, collaboration, and innovation in quality management.

I am a dedicated Quality Assurance Specialist with a strong background in ensuring compliance with cGMPs and quality standards in the biopharmaceutical industry. My experience at KBI Biopharma has equipped me with the skills to lead investigations, manage quality documents, and collaborate effectively across various departments to enhance product quality.

With a Master’s degree in Bioinformatics and a certification as an ASQ Certified Quality Auditor, I have a solid foundation in both scientific principles and quality management practices. I excel in data analysis and reporting, utilizing KPIs to drive process improvements and support management decisions. My previous role as an Analytical Chemist at Procter & Gamble further honed my analytical skills and regulatory knowledge, allowing me to thrive in a fast-paced, regulated environment.

Experience

Work history, roles, and key accomplishments

Current

Quality Assurance Specialist

Current

KBI Biopharma

Dec 2020 - Present (4 years 7 months)

Assisted with lot review and release activities for drug substances, drug products, and finished goods, ensuring compliance with cGMPs and company quality standards. Led and supported investigations including root cause analysis (RCA), corrective and preventive actions (CAPAs), change controls, deviations, and Vendor Change Notifications to resolve quality issues and ensure continuous improvement.

Root Cause Analysis CAPA Change Control SOPs Quality Auditing Document Control ETQ Reliance

Analytical Chemist

Procter & Gamble Co.

Jan 2019 - Dec 2020 (1 year 11 months)

Conducted analytical testing using techniques such as HPLC, GC-MS, and FTIR. Maintained instruments and supported cGMP compliance in a regulated laboratory setting.

GC MS FTIR

Education

Degrees, certifications, and relevant coursework

North Carolina Central University

Bachelor of Science, Biology

Completed a Bachelor of Science in Biology, gaining foundational knowledge in biological sciences. This program provided a strong scientific background.

University of North Carolina at Charlotte

Master of Science, Bioinformatics

Pursued a Master of Science in Bioinformatics, focusing on the intersection of biology and information technology. This advanced degree enhanced skills in data analysis and computational biology.