About this role
About the Role
The Quality Assurance Specialist will be responsible for ensuring that Sartorius products and services meet established standards. This role focuses on maintaining robust quality control through GLP compliance, quality management systems, and alignment with reliability, performance, and customer expectations.
What You'll Do
- Manage the GLP Quality Management System (QMS), including document control, change control, and training management.
- Manage and maintain laboratory equipment.
- Conduct and oversee environmental monitoring activities.
- Ensure compliance with data integrity requirements and related quality processes.
- What We're Looking For
- Bachelor's degree or higher.
- Minimum 3 years of experience in Quality Assurance (QA) or GLP compliance-related activities.
- Strong understanding of GLP regulations and quality management systems.
- Experience in risk-based inspection, audit, and compliance management.
- Nice to Have
- Experience with alternative (non-animal) testing methods.
- Experience in virus validation studies and related quality oversight.
- Professional QA certifications are preferred.
- Experience supporting inspections and audits conducted by domestic and international regulatory authorities.