Quality Systems Specialist I

📋 Description

• Provide support in the management of Quality Management System
• Create, issue, and reconcile production batch records, labels, and logbooks
• Organize, maintain, and ensure proper storage of physical and electronic quality records
• Prepare and manage offsite storage of controlled records, including review, scanning, and scheduling transfer
• Provide administrative support for Quality Systems, including meeting coordination and action items tracking
• Assist in audit preparation, tracking audit responses, and Corrective Actions

🎯 Requirements

• Bachelor’s degree with 0-2 years in biotech/pharma quality or GxP
• MS Office Suite (Word, Excel, PowerPoint)
• Excellent organizational skills; multitask and prioritize
• Cross-functional collaboration skills
• Knowledge of cGMP/ICH/FDA GMP for cell/gene therapy preferred
• Veeva Vault QMS, eDMS, LMS experience; technical writing a plus

🎁 Benefits

• People-first culture and inclusive environment
• Commitment to diversity and equal opportunity
• Career development and growth opportunities
• Competitive pay and benefits