Quality Control Engineer II - Center for Regenerative Biotherapeutics
On-site · Rochester, Minnesota, United States
Job Summary
Quality Control Engineer II at Mayo Clinic's Center for Regenerative Biotherapeutics (CRB) performs quality control assays (release, in-process, and stability tests), conducts environmental monitoring in clean rooms, and leads assay development and validation tasks. Responsible for qualification and validation support of manufacturing processes essential to clinical production, and for GMP-related activities in accordance with SOPs, with emphasis on data integrity and good documentation practices. Supports investigations, CAPAs, Change Controls, and regulatory/audit activities; participates in identifying, optimizing, and validating analytical procedures; may assist in reviewing/revising SOPs; performs general lab duties; and completes required training while training others as qualified.
Required Qualifications
- Perform GMP-related activities per SOPs
- Compliance with cGMP and Data Integrity
- Environmental monitoring in clean rooms
- Lead assay development and validation tasks
- Provide qualification and validation support for manufacturing processes
- Documentation in line with good documentation practices
- Assist in reviews of SOPs and participate in audits
- Complete and maintain required training and train others
Desired Qualifications
- GMP/cGMP experience
- Environmental monitoring
- Assay development and validation
- CAPA and Change Controls
- SOPs and documentation
- Training others
- Audits and regulatory compliance
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