🛠 Tech Stack

💼 About This Role

You'll support Environmental Monitoring and Microbiological testing in a GMP-regulated biotech facility developing cell-based therapies for chronic kidney disease. You'll mentor junior analysts and drive continuous improvement in QC operations. This role offers the chance to impact first-in-class treatments that may prevent dialysis.

🎯 What You'll Do

• Perform Change Control and CAPA investigations with timely closure
• Conduct routine Environmental Monitoring of classified GMP areas
• Operate, maintain and troubleshoot EM and laboratory equipment
• Review and maintain SOPs, Work Instructions, and protocols

📋 Requirements

• Bachelor's degree in science or technical discipline preferred
• 3-5 years of quality systems experience in regulated pharma/biotech/medical device
• Working knowledge of Deviations, CAPA, Change Control and Document Control

✨ Nice to Have

• Experience with commercial manufacturing and cleanroom monitoring
• Hands-on experience with electronic QMS, particularly MasterControl
• LIMS or sample management program experience

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Phone Screen· 30 min
2. 2Technical Interview· 60 min
3. 3On-site Interview· 90 min