🛠 Tech Stack

💼 About This Role

You'll provide QA oversight for commissioning and qualification activities in a cGMP environment. You'll ensure compliance with regulatory requirements for manufacturing suites and QC labs. This role offers the chance to work with advanced therapies in a technology-driven biotech company.

🎯 What You'll Do

• Provide QA oversight of CQV activities for cGMP facility and QC labs
• Review CMMS records for asset management and work orders
• Oversee quality events for validation and engineering operations
• Author and review SOPs in Veeva

📋 Requirements

• Bachelor's degree with 3+ years validation or QA experience
• Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5
• Experience in cell and gene therapy manufacturing preferred
• Experience with Kneat strongly preferred

✨ Nice to Have

• Experience with contract manufacturing
• Risk-based decision making skills
• Collaborative problem-solving approach

🎁 Benefits & Perks

• 💰 Competitive hourly rate $43.27-$57.69/hr

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

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