💼 About This Role

You'll support quality operations for a CDMO focused on immune cell therapies, reviewing production documents and ensuring cGMP compliance. Your work directly impacts the release of drug substances and products for clinical studies.

🎯 What You'll Do

• Review production batch records, testing forms, and logbooks for cGMP compliance.
• Generate and revise product-related master documents for GMP manufacturing.
• Support deviation, CAPA, and change control activities.
• Assist in regulatory and client audits and inspections.

📋 Requirements

• HS Diploma with 7+ years relevant industry experience
• Experience with FDA Good Manufacturing Practices (GMPs) in pharmaceutical or biologic industries
• Proficiency in Microsoft Word and Excel

✨ Nice to Have

• Bachelor's degree in life sciences
• Exposure to 21 CFR Parts 210/211/820 and biotechnology

🎁 Benefits & Perks

• 🏖️ Competitive benefits package

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Phone Screen· 30 min
2. 2Interview with Hiring Manager· 60 min
3. 3Offer· N/A

🚩 Heads Up

• Requires 7+ years with HS diploma but only 2+ years with bachelor's—possible overqualification for role title