- Investigate and close non conformances, deviations, change controls, and other quality system controls
- Support department in audit proceedings and preparations
- Final Batch History Record review for compliance
- Training of production operators on procedural and documentation updates
- Maintenance of training records for department
- Support and Implement continuous improvements
- Support coordinators in Line Clearance
- Bachelors Degree in Science or Engineering with 2+ years experience or Masters degree in relevant field
- Experience in Quality Systems
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Quality Specialist II - Callaghan, Australia - Danaher
Description
Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Quality Specialist for Immunoassay/Blood Virus for Beckman Coulter Diagnostics is responsible for the generation, investigation and implementation of actions arising from Non conformances, complaints and deviations within the department, as well as the maintenance of operator training records. The Quality Specialist also reviews batch history records and completes change controls and supports continuous improvement efforts.
This position is part of the Production Operations team located in just outside Tulla in Lismeehan, O'Callaghan's Mills, Co. Clare and will be based onsite. Our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the IA/BV Production Operations team reporting to the Production Supervisor and will be responsible for quality investigations, procedural updates, BHR compliance as well as support of audit preparations and continuous improvements. If you thrive in a multifunctional, fast paced, supporting role and want to work to build a world-class production organization—read on.
In this role, you will have the opportunity to:
Education & Experience
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit .
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.