🛠 Tech Stack

💼 About This Role

You'll serve as a quality resource for GMP quality systems at a state-of-the-art gene therapy facility. You'll drive root cause analysis and CAPA implementation to ensure regulatory compliance and continuous improvement. This role offers hands-on impact in a purpose-driven biotech.

🎯 What You'll Do

• Serve as quality resource for deviation, CAPA, and change control processes.
• Author and review investigations and controlled documentation like SOPs.
• Identify and implement continuous improvement items via CAPA.
• Support internal and external audits as needed.

📋 Requirements

• Bachelor's Degree in biological or STEM field (or equivalent).
• Strong expertise in deviation management including root cause analysis.
• Thorough knowledge of Good Documentation Practices (GDP).
• Experience in a GxP environment with cGMP and FDA/EU regulations.

✨ Nice to Have

• Experience with root cause analysis and technical writing.
• Knowledge of biopharmaceutical manufacturing workflows.
• Experience with Veeva Vault QMS.

🎁 Benefits & Perks

• 🏥 Health, dental, vision insurance from day one with 90% premium coverage.
• 🏖️ Competitive PTO plus 12 weeks paid parental leave.
• 💰 Annual bonus opportunities and 401(k) with company match.
• 💪 Onsite fitness facility and Employee Assistance Program.
• 🍎 Fully stocked kitchen with free snacks and beverages.

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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