Featured Member: Keara Coffield on HBCU CONNECT!

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Keara Coffield
Validation Engineer, Quality Agents
Location: Dundalk, MD United States
Joined: Jul 12th, 2016

About (request update)

Education (request update)

Hampton University class of 2016

Undergrad Major: Chemical Engineering

North Carolina A&T State University class of 2019

Grad Major: Chemical Engineering

High School: Riverside High School in Durham, NC class of 2012

Experience

I currently work with Quality Agents as Validation Engineer
I have 4 years of experience working in the Biotechnology and Pharmaceutical industry.

QA Validation Specialist | Quality Agents
From August 2023 to Current • 3 year(s)
Author and execute qualification protocols for new system implementation and changes to existing systems. Interface with system owners, IT, and facilities engineering to ensure compliance requirements are tested.

Consultant II | Azzur Group
From February 2023 to July 2023 • 0 year(s)
Professional service provider for pharmaceutical companies providing Quality, Compliance, Validation, IT, Engineering, Project Management, and Regulatory Services.

Lead Validation Engineer | Catalent Pharma Solutions
From August 2022 to February 2023 • 1 year(s)
Project lead for CPV Projects including statistical analysis and troubleshooting investigations. Supported protocol execution, data gathering, and report development for Cell and Gene Therapy.

Supply Chain Logistics Process Engineer | Coty Inc.
From March 2022 to August 2022 • 0 year(s)
Identified, prioritized and eliminated process losses and built process capability and controls. Analyzed critical line data to make recommendations for improvement from trends.

Process Validation Engineer | Catalent Pharma - PBI
From February 2021 to March 2022 • 1 year(s)
Generated qualification protocols for various processes in the facility. Worked closely with Manufacturing, QA/QC and Facilities staff in execution of validation activities.

Associate Specialist Engineer II (Contractor) | Merck and Company
From September 2019 to January 2021 • 2 year(s)
Coordinated change controls for scheduling and compliance requirements for antibiotic bulk and sterile supply areas. Conducted impact assessments and tracked metrics for key projects.

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Guestbook Comments

	It's my pleasure to have you join, us as a new or seasoned member. May you have an amazing, blessed and marvelous day Tagged by Ralph White on 11/23/2023

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