Sobre este puesto de Quality Specialist en Danaher
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
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. Take your next step to an altogether life-changing career.
Learn about the Danaher Business System which makes everything possible.
The Quality Specialist 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 reports to the Sr. Quality Manager and is part of the Quality and Regulatory Affairs team located in Songdo, Incheon and will be an on-site role.
What you will do:
- Perform production release activities as a Quality Assurance representative in accordance with company policies, procedures, and compliance requirements
- Perform destructive analysis on returned complaint samples to support complaint investigations
- Perform outlier analysis to identify abnormal data points and distinguish between common cause and special cause variations
- Support Quality Assurance activities including audits and documentation control (Change Control, Deviation handling, Complaint investigation, CAPA, Risk Assessment, Calibration, Validation, etc.) in accordance with the Quality Management System (Veeva)Perform production release as a Quality Assurance in accordance with Company compliance and procedure
Who you are:
- Minimum, bachelor’s degree from an accredited University or College, preferably in Biological Science and/or Microbiology
- 3 or more years of related Quality Assurance or Quality Engineering experience
- Agreeable personality, able to communicate effectively at all levels both internal and external to Cytiva
- Comprehensive understanding of ISO 9001, GMP, and GDP 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/Laboratory experience desirable in Pharmaceutical Industry
Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
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.
