Open to opportunities

HyeMin Yu

@hyeminyu

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Highly capable Sr. QA Specialist with pharmaceutical industry experience.

South Korea

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What I'm looking for

I am looking for a role that offers growth opportunities and values quality management.

I am a highly capable Senior QA Specialist with over six years of experience in the pharmaceutical industry. My focus has been on developing Quality Management System (QMS) compliance and providing technical and quality support to various teams and contract manufacturers. I pride myself on being a reliable and organized team player, with a strong ability to communicate effectively and efficiently.

Throughout my career, I have successfully managed quality compliance, including complaint management and post-approval change management, leading to significant achievements such as US-FDA and EU-GMP approvals. My role at Janssen Vaccines has allowed me to implement quality on-the-shop-floor activities and investigate quality issues to maintain data integrity. I am driven by a passion for continuous improvement and the desire to ensure that all products meet the highest quality standards.

Experience

Work history, roles, and key accomplishments

Current

Sr. QA Specialist

Current

Janssen Vaccines

Jun 2021 - Present (4 years)

Highly capable Sr. QA Specialist with over 6 years of experience in the pharmaceutical industry. Responsible for developing QMS compliance and providing technical support to teams and contract manufacturers to resolve quality issues. Skilled in supplier management, data integrity, and quality oversight.

Supplier Management Data Integrity Regulatory Compliance Risk Assessment Communication Skills Project Management

Current

Sr. QA Specialist

Current

Janssen Vaccines

Jun 2021 - Present (4 years)

As a Sr. QA Specialist, I focused on developing QMS compliance and providing technical support to resolve quality issues. I approved Data Integrity documents and supervised supplier management, ensuring quality governance and compliance with regulatory requirements.

Data Integrity Supplier Management Regulatory Compliance Risk Assessment Communication Skills

Commercial Quality Specialist

Janssen Korea

Apr 2021 - Oct 2021 (6 months)

Managed market quality compliance, including complaint management and post-approval change management. Ensured adherence to US-FDA and EU-GMP standards through effective communication with stakeholders.

Change Management Quality Investigations Regulatory Requirements Problem Solving

Compliance QA Specialist

Celltrion Pharm.

Sep 2017 - Feb 2020 (2 years 5 months)

Oversaw product quality compliance and coordinated external audits. Managed quality oversight for various departments including MTO, QC, and QA, ensuring compliance with global regulatory standards.

Externe Audits Regulatory Compliance Quality Management Systems Audit Trail Review Team Coordination Risk Management

Commercial Quality Specialist

Janssen Korea

Apr 2021 - Oct 2021 (6 months)

Managed market quality compliance, complaint management, and post-approval change management. Ensured adherence to US-FDA and EU-GMP regulations through effective communication and quality investigations.

Regulatory Compliance Quality Investigations Communication Skills Change Management Quality Assurance Documentation Problem Solving Team Collaboration

Compliance QA Specialist

Celltrion Pharm.

Sep 2017 - Feb 2020 (2 years 5 months)

Oversaw product quality compliance and coordinated external audits with regulatory bodies. Managed quality oversight for various departments, ensuring adherence to quality standards and regulations.

Externe Audits Regulatory Compliance Quality Management Systems Audit Trail Review Communication Skills Team Coordination

Intern

National Research Council of Science & Technology

May 2017 - Aug 2017 (3 months)

Assisted in assessing research projects for government initiatives. Gained experience in quality management and compliance within a scientific research environment.

Quality Management Compliance Data Analysis Team Collaboration Communication Skills Project Coordination Problem Solving Technical Support Documentation

Intern

National Research Council of Science & Technology

May 2017 - Aug 2017 (3 months)

Assisted in assessing research projects for government initiatives. Gained experience in quality management and compliance processes within a scientific research environment.

Quality Management Compliance Data Integrity Team Collaboration Communication Skills Problem Solving Technical Support Project Coordination

Education

Degrees, certifications, and relevant coursework

National Research Council of Science & Technology

Internship, Research

2017 - 2017

Internship focused on assessing research projects and ensuring compliance with government standards.

Chungbuk National University

Bachelor of Science, Biochemistry

2011 - 2017

Completed a Bachelor of Science in Biochemistry, focusing on supplier/material management, data integrity, and project leadership in quality assurance.