Quality Coordinator Kitbuilding/sample Handling
il y a 8 heures
As Quality Coordinator you are responsible for managing and coordinating key quality tasks to ensure compliance and quality within the department.
**You will be responsible for**
Freezer Compliance & Monitoring:
- Ensure monitoring system is operating as expected and warnings & alarms are addressed appropriately.
- Perform validation tasks per SOP schedules to maintain compliance (mapping, start up qualification, etc.)
- General freezer monitoring to ensure proper operation.
- Inform the appropriate team member(s) of maintenance and repair requirements.
Kit Quality Inspections:
- Perform or coordinate the required kit quality inspections.
- Track and report results & metrics.
Documentation & Investigations:
- Assist department with documentation requirements - SOP’s, WI’s, etc.
- Assist department with addressing and closing CAPA’s and Quality Events.
Audits & Audit Readiness:
- Develop plan, schedule, and perform internal audits within department.
- Participate and support department during customer audits.
- Facilitate “Audit Readiness” within the department.
- Support the team to complete or investigate Quality Events, CAPA’s, audit findings.
Perform Cycle Counts of Sample/Kit Building Inventory.
Identify process improvements & work with department managers to implement.
Collaborate with global peers to drive consistency across the organization in the development of global processes and procedures.
Any other tasks that may arise to support the kit building/sample handling and Logistics team.
In this role you report into Regional Head KitBuilding, Sample Handling and Logistics.
**Qualifications (Education and Experience)**:
- You have a Bachelor’s degree or equivalent experience on that level.
- Laboratory experience is preferred, Freezer & Biorepository experience is an advantage.
- Experience writing SOP’s, Investigations, and other quality documents in a GMP environment.
- You have strong administrative skills, and you are detail oriented.
- You like to work in a team.
- You speak and write fluent in Dutch and English.
**Working at Cerba Research**
Cerba Research is growing fast on a global scale. Working at Cerba Research first of all means that you contribute to improve global health. It also means growing your career in a dynamic, fast paced environment, where you can develop new skills and work on diverse projects. There is plenty of room for initiatives, we encourage you to take ownership, cooperate, keep learning and most and for all, have fun
**Sounds like you? Then please contact us, we would love to meet you
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