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…
Skills: Quality Assurance, Quality Engineering, ISO 9001, GMP, GDP
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Full-time
bachelor degree
Health Care Program, Paid Time Off
Posted 50d ago
~40 hrs/week
Responsibilities
The Quality Specialist provides QMS support to ensure compliant execution, monitoring, and continuous improvement of Quality Control. Key tasks include performing production release activities, conducting destructive analysis on complaint samples, and managing documentation control.
Requirements
Candidates must have a bachelor's degree in Biological Science or Microbiology and at least 3 years of experience in Quality Assurance or Engineering. Fluency in both English and Korean is required, along with a comprehensive understanding of ISO 9001, GMP, and GDP requirements.
Full job description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
AtCytiva, one ofDanaher’s15+ 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. Andby harnessingDanaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Working atCytivameans 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.
AtCytivayou 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.
TheQuality Specialistis responsibleforQMS 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 theSr. Quality Managerand is part of theQuality and Regulatory Affairs teamlocatedinSongdo, Incheonand willbe 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 atDanaher 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.
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. We partner with customers around the world to accelerate breakthroughs from idea to impact, moving with the speed and certainty they need to advance life‑changing science.
By working side‑by‑side with researchers, scientists, and clinicians, we solve their hardest problems—together, bringing the right expertise, technologies, and partners from across our portfolio to architect the most effective solutions.
Through our connected ecosystem of companies operating at global scale, we help customers streamline and integrate their workflows across Life Sciences, Diagnostics, Biotechnology, and beyond—empowering them to achieve results faster, with greater confidence.
Offices: 2200 Pennsylvania Ave NW, 800 W, Washington, District of Columbia 20037, US
Life SciencesDiagnosticsand BiotechnologyHealth DiagnosticsHealth CareCommunications InfrastructureBiotechnologyLife ScienceMedical
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