Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The Senior Quality Specialist for Cytiva is responsible for QMS support to the Senior Quality Manager to ensure compliant execution, monitoring, and continuous improvement of QMS and Quality Control in line with certification requirements and customer expectations.
This position is part of the Quality and Regulatory Affairs team located in Song-do, Incheon, South Korea and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
- 30% Quality Control and 70% Quality Assurance tasks
- Support QA duties as required including Audit support, Documentation Control (Change Control, Deviation handling, Complaint investigation, CAPA, Risk assessment, Calibration, Validation, etc.).
- Support QC Laboratory duties as required including Quality Control and QC release testing.
- Maintain the Quality Management System in accordance with Corporate, BU and Regulatory Requirements and set up and maintenance of LIMS in new site.
- Implement continuous improvement practices in new plant site, including supporting kaizen events for relevant Quality processes.
Who you are:
- Minimum, Bachelor’s degree from an accredited University or College, preferably in a Science or Engineering discipline
- 5 or more years of related quality experience
- Agreeable personality, able to communicate effectively at all levels both internal and external to Cytiva
- Comprehensive understanding of ISO 9001, GMP, and QMS requirements
- Strong analytical- and problem-solving skills.
Travel, Motor Vehicle Record & Physical/Language/ Environment Requirements:
- Fluent level of English & Korean in written and verbal communications 한국어 및 영어로의 서면 및 구두 의사소통능력이 뛰어난 분
- Ability to travel abroad upon business needs 해외여행에 결격 사유가 없으신 분
- Must have a valid driver’s license with an acceptable driving record within territory or locations 운전을 하여 담당하는 국내 고객사에 방문할 수 있는 분
- If foreign national, legal work permit is required to pursue employment contract by Korean immigration law 대한민국에서의 근무가 가능한 비자가 있는 분
- Ability and resilience to manage required chemical materials to pursue task in healthy and safe condition 업무 수행이 필요한 화학 물질을 건강하고 안전한 조건에서 다룰 수 있는 분
- Ability to lift, move or carry equipment, any other physical requirements
- 들어 올리거나 이동하거나 운반할 수 있는 능력, 기타 물리적 요구 사항
It would be a plus if you also possess previous experience in:
- Desirable: Knowledge of Lean tools (like DBS) and understanding of Cytiva products
- Internal Audit against applicable ISO 9001 and GMP standards
- Quality Assurance/Quality Control/Quality Engineering experience in mechanical/manufacturing engineering
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
