Quality Complaint Expert (대전 바이오 공장, 3년 이상의 제약/바이오 Quality 경력)

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

Overall Objectives of the Position

The Quality Complaint Expert will support the establishment of the APAC Quality Investigation Center and manage the full operation of customer complaint investigations in a timely manner.

The Quality Complaint Expert will conduct analytical tests on locally returned products, document the results appropriately in the Complaint Management System to facilitate customer responses, and assist in basic troubleshooting of received issues.

Your Role

• Safely set up the new facility and qualify and maintain lab test equipment throughout its life cycle, including installation, operational qualification, and preventive maintenance.
• Manage complaint returns from local customers in accordance with Standard Operating Procedures.
• Conduct analytical tests on returned materials for complaint investigations.
• Routinely review and verify test data for accuracy and reliability to ensure data integrity.
• Prepare documentation, including customer reports for complaint investigations, and record the data in the Quality Management System according to internal procedures and customer-specific demands.
• Communicate and collaborate effectively with manufacturing sites to jointly perform root cause analysis and develop CAPA plans.
• Regularly assess the overall performance of the Quality Investigation Center and conduct trend analysis of complaint investigation results.
• Review and revise controlled documents as appropriate to maintain up-to-date procedures and meet customer expectations.
• Support site inspections and customer visits as required.
• Maintain a sufficient inventory of materials necessary for daily operations.
• If necessary, support adjacent QA groups within the quality management system.
• Participate in sustainability efforts and proactively identify and report safety, quality, and productivity concerns, including hazardous conditions or behaviors observed in the working environment and on site.

Who You Are

• Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, or a related discipline.
• Over 3 years of experience in the pharmaceutical, life science, biotechnology, or medical device industry.
• Experience with FT-IR, UPLC, and integrity testing for single-use assemblies and process filters (Bubble point, Diffusion test) is a plus.
• A high degree of accuracy and attention to detail, along with excellent interpersonal, oral, and written communication skills in English.
• Excellent problem-solving and organizational skills; attentive, careful, and meticulous, with strong teamwork abilities.
• Technical writing skills for investigation summaries.
• Basic computer skills, with familiarity with Microsoft Office applications and eQMS preferred.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!