At Beckman Coulter Diagnostics, we are dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Our company is proud to work alongside a community of six fellow Diagnostics Companies at Danaher.
We are building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. You will be part of a team that develops strong, positive and beneficial working relationships and effective information flow with other departments and within the Project team and Quality department.
About This Role
This position is responsible for ensuring Quality Project deliverables are achieved, coordinating the creation, review and approval of non-conformances, Equipment Change Controls, Manufacturing Documentation in support of the Quality Management System.
You will provide Quality expertise during investigations and daily manufacturing issues driving process improvements. As a member of the R&D QA Team, you will report to the Blood Virus Quality Manager and support cross functional teams providing Quality guidance and support to all departments.
* Be responsible for the support of the New Product Development Process specifically Patient Sample Manufacture within BCII.
* Support the Non-conformance processes (NCs) ensuring compliance to Quality and Regulatory Standards.
* Support creation, review and approval of Equipment and Manufacturing documentation.
* Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures to support Project Deliverables.
* Review and approval/release of Batch History Records.
The essential requirements of the job include:
* Bachelor's degree (Honours Level 8) in chemistry, biochemistry, biology or other relevant technical field with a minimum of 0-2 years experience in a highly regulated (FDA desirable) healthcare or related environment.
* Strong team player with the ability to identify and drive quality improvements.
* Be competent in working independently.
* Excellent planning and organisational skills with the capacity to rapidly switch between tasks at ease.