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Aundrea Bobenmoyer

@aundreabobenmoyer

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Experienced Quality Engineer with a strong background in biopharmaceuticals.

United States

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What I'm looking for

I am seeking a role that fosters collaboration and innovation, where I can leverage my quality assurance expertise to drive compliance and operational excellence.

I am a dedicated and professional Quality Engineer with over 9 years of experience in the biopharmaceutical and pharmaceutical industries. My journey began with a Bachelor of Science in Chemistry from Radford University, where I developed a strong foundation in scientific principles and regulatory compliance. I have honed my skills in quality assurance, internal and external audits, and regulatory standards, ensuring that organizations meet and exceed compliance requirements.

In my current role as a Senior Quality Engineer at Umoja Biopharma, I lead site-wide projects and implement corrective and preventative actions while performing risk assessments and root cause analysis. My previous experience at AGC Biologics and AstraZeneca has equipped me with the ability to manage complex QA operations, develop metrics for cross-functional teams, and support manufacturing activities. I pride myself on my exceptional communication skills and my ability to build strong relationships with colleagues and clients alike.

Experience

Work history, roles, and key accomplishments

Current

Senior Quality Engineer

Current

Umoja Biopharma

Oct 2023 - Present (1 year 9 months)

Conducted internal and external audits to assess compliance with regulations and standards. Implemented and assisted with corrective and preventative actions, performing risk assessments, root cause analysis, and deviations.

GLP Auditing Risk Assessment Root Cause Analysis CAPA Quality Assurance Project Management Cross Functional Team Leadership

Senior Quality Assurance Specialist

AGC Biologics

Mar 2022 - Oct 2023 (1 year 7 months)

Managed and led triage meetings for events, deviations, and investigations for manufacturing, validation, and quality control. Provided QA support for manufacturing activities and represented QA for customer interactions.

QA Manufacturing Validation Quality Control Technical Documentation Batch Record Review Deviation Management CAPA

Quality Assurance Specialist III

AstraZeneca

Jun 2021 - Mar 2022 (9 months)

Performed on-the-floor activities including changeovers, PACs, and equipment cleaning. Created and revised QA documents such as SOPs, technical reports, and risk assessments in the document management system.

SOPs Risk Assessment Deviation Review Root Cause Analysis Batch Record Review Manufacturing Operations

Quality Assurance Specialist OPS (QA Associate II)

Catalent Pharma Solutions

Feb 2021 - Jun 2021 (4 months)

Reviewed technical documents including SOPs, deviations, change controls, CAPAs, and effectiveness checks. Performed QA on-the-floor activities supporting client products, including room release and observing critical processes.

SOPs Change Control CAPA QA On The Floor Batch Record Disposition

Quality Assurance Associate

Supernus Pharmaceuticals Inc.

Dec 2017 - Feb 2021 (3 years 2 months)

Led and assisted in the preparation, execution, reporting, and follow-up for internal and external audits, CAPA recommendations, and risk assessments. Worked with various departments as a Quality Assurance Representative.

Internal Audit Externe Audits CAPA Risk Assessment Document Review Batch Record Review Quality Assurance Regulatory Compliance

Education

Degrees, certifications, and relevant coursework

Radford University

Bachelor of Science, Chemistry

Obtained a Bachelor of Science in Chemistry with a concentration in Pre-Health. This program provided a strong foundation in chemical principles relevant to healthcare.