Angela Hurst-Johnson

Served as a Quality consultant, guiding top management in modifying current quality practices and transforming the company's Quality Culture. Provided assistance on various Quality issues impacting manufacturing, collaborating with management and other consultants to review quality documents for best practices.

Led drug release activities, ensuring 100% on-time product release and compliance with 21 CFR Part 11 and ICH guidelines. Managed U.S. and EU clinical drug release processes, achieving seamless operations and audit readiness.

Oversaw quality control and lab activities, ensuring compliance and efficiency, and reviewed and approved Quality documents. Led cross-functional quality initiatives and vendor management, optimizing laboratory operations that drove 40% efficiency gains in testing turnaround times.

Investigated EM deviations in pharma facility, identifying root causes and corrective actions. Developed CAPA plans with manufacturing, ensuring compliance and process improvement.

Conducted deviation investigations for drug product manufacturing, implementing effective CAPAs and effectiveness checks to address root causes. Utilized Six Sigma Methodology for root cause analysis and drove all deviations to closure within 30 days.

Performed impact assessment on approximately 700 pharmaceutical products and provided Document Control and Batch Record review prior to release. Structured FDA compliant investigations for Potency and Environmental Monitoring ISO5 and ISO7 areas.

Instituted plans and documents to operate in an FDA regulated environment under guidelines of FDA 21 CFR Part 11, 210, 211, 820 and sect 503B. Executed plans for full establishment and commissioning of both Sterility and Analytical quality control testing labs.

Responsible for the accuracy of QC Microbiology and Analytical Chemistry testing laboratory results and test methods provided by technicians.

Performed work in an EPA regulated environment under federal guidelines of 40 CFR Part 414. Reviewed all Quality Control, Microbiology and Analytical testing data for conformance and accuracy.

Collaborated with global lab personnel to align methods for ISO9001 certification. Examined all necessary method validation documentation (protocols, methods SOP reports).

Activities and societies: Thesis: 'The Design and Synthesis of Corannulene Based Nanomaterials' under Research Advisor Dr. James Mack

Completed a Master of Science in Organic Chemistry. My thesis focused on 'The Design and Synthesis of Corannulene Based Nanomaterials' under the guidance of Dr. James Mack.

Activities and societies: Undergraduate Thesis: 'The Design and Functionalization of Calixarene Molecules' under Research Advisor Dr. Carl Johnson

Obtained a dual Bachelor of Science degree in Chemistry and Mathematics. My undergraduate thesis was titled 'The Design and Functionalization of Calixarene Molecules' under Dr. Carl Johnson.

Completed a Green Belt Certification in Six Sigma. This certification enhanced my skills in process improvement and quality management methodologies.