🛠 Tech Stack

💼 About This Role

You'll be the primary business user for the Veeva LIMS within the Quality Control group, building and maintaining test definitions and sample plans. You'll ensure data integrity and inspection readiness for AAV gene therapy programs. This role offers the chance to work at a state-of-the-art cGMP facility in Columbus.

🎯 What You'll Do

• Provide Tier 1 LIMS support to QC users
• Build and maintain test definitions and sampling plans in Veeva LIMS
• Configure and issue Certificates of Analysis and Testing
• Develop SOPs and training materials for LIMS use

📋 Requirements

• AS/BS in Life Sciences, Biotechnology, or related field
• GxP-regulated laboratory experience (biologics or gene therapy preferred)
• Veeva LIMS or equivalent enterprise LIMS platform experience
• FDA 21 CFR Part 11 and GMP compliance knowledge

✨ Nice to Have

• Understanding of AAV or viral vector manufacturing processes
• Database management and system validation experience
• Exposure to regulatory inspections with LIMS documentation

🎁 Benefits & Perks

• 🏥 Health Insurance
• 🏖️ PTO
• 📈 Career Development
• 🏢 Onsite Work at The Hearth facility

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Phone Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Technical Interview· 60 min