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Immucor Inc., a global in vitro diagnostics (IVD) company with headquarters in Atlanta, USA, is a company specialized in immunohematology and corresponding automation systems. We distribute a full line of traditional immunohematology reagents and fully automated instruments and data management software to drive efficiency and productivity. Immucor strives to improve the quality of pre-transfusion testing by driving the implementation of automation especially for university hospitals and transfusion centers, blood donation services for hospitals and laboratory physicians. Our history of laboratory automation began in 1998 and since then we have continuously invested in generation systems.
To support our RA/QA team as part of the IVDR project, we are now looking for a temporary person for the Dreieich location
Laboratory Specialist (m/w/d)
(e.g. scientific assistant)
Range of tasks:
- Support of the overall project of transferring products to the IVDR (EU) 2017/746
- Quality monitoring of IVD products according to ISO 13485, ISO 9001, IVDD, IVDR, cGMP standards and applicable national laws and guidelines
- Determine necessary steps to perform performance and stability studies required by applicable regulations and directives, including preparation of related documentation.
- Support of Quality Control Processes especially prepares and maintains departmental SOPs
- Support analysis of critical performance data for regular product review meetings to keep quality, regulatory, manufacturing and development departments abreast of current product issues.
- Ensure adequate documentation of European and global regulations and standards
Your profile:
- Master's degree in biology, biotechnology or another related scientific discipline or comparable and already some work experience in a laboratory field for medical devices
- Ability to apply knowledge of ISO 13485, ISO 9001, ISO 14971, IVDD, IVDR and cGMP standards to the job
- You have very good knowledge of German and English
- You act with a strong service orientation, show excellent analytical and organizational skills
- Extensive PC knowledge, especially in Microsoft Office (Word, Excel, PowerPoint)
- Your outstanding teamwork and communication skills combined with commitment and conscientious working methods are prerequisites for this demanding task.
- Our corporate values of respect, integrity, teamwork and performance match your values.
We offer:
- Working in an innovative, and forward-thinking company
- Challenging and versatile tasks in a motivated, international team
- Flexible working hours with home office option
- Sympathetic and cooperative working environment with a demanding and challenging work
- Security of an established, successful company
- Central location with good infrastructure in the Rhine-Main-area
- Regular Feedback about your personal and career development
Are you interested?
Then please send us your full application in German and/or English, stating your earliest possible starting date and salary expectations by email to
bewerbung@immucor.comE-Mail Adresse anzeigen
Then please send us your full application in German and/or English, stating your earliest possible starting date and salary expectations by email to
Mrs. Dr. Paulina Nowakowska, Sr. Manager Quality Operations and / or
Mrs. Franziska Hruby, HR Generalist
Immucor Medizinische Diagnostik GmbH | Robert-Bosch-Str. 32 | D-63303 Dreieich