Quality Assurance Specialist
vor 6 Monaten
**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 **Quality Assurance Specialist** (M/F/d) for Cytiva is responsible to support QA operations in the viral vector cell line development business.
This position is part of the Viral Vector business unit in the Genomic Medicine Operation Company located in Cologne, will be hybrid and temporary for 24 months. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
**What you will do**:
- Creation, review and training of SOPs and other quality related documents or procedures
- Administration of e.g., documents in the electronic DMS system and support the administration and maintenance of our laboratory monitoring system
- Change control and deviation management, follow up on required corrective and preventive actions, monitoring of corresponding measures
- Monitoring and approval of internal and external cell bank tests
- Support the teams in continuous improvement of internal processes using tools as Kaizen
**Who you are**:
- Degree in Biology, Biotechnology or comparable qualification
- Demonstrated experience to understand Quality requirements related to ISO 9001
- Computer literate (Word, Excel, Electronic Documentation System)
- Proven experience in a global working environment
- Fluent in written and spoken English
**It would be a plus if you also possess previous experience in**:
- Preferably Quality Management experience according to e.g. ISO 9001 or ISO 13485
- Ideally even good knowledge in current GMP regulations
- Knowledge of laboratory or cell culture work
**Benefits**
- Attractive salary
- Development opportunities at Cytiva and within the Danaher Group
- International corporate environment in a rapidly growing industry
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.
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