GMP Quality Assurance Specialist - Remote

Overview

The GMP Quality Assurance Specialist plays a critical role in ensuring compliance with current Good Manufacturing Practices and internal quality standards within a biopharmaceutical company focused on treating metabolic liver diseases.

In Short

• Support Quality Event Management program
• Manage deviations and CAPA system
• Assist with batch disposition process
• Collaborate with cross-functional teams
• Ensure timely entry and closure of quality events
• Track CAPA lifecycle and effectiveness checks
• Prepare for internal audits and regulatory inspections
• Compile and analyze quality metrics
• Revise and update SOPs related to quality management
• Work in a dynamic, inclusive culture

Requirements

• 3+ years of relevant experience
• BS in scientific discipline
• Experience in pharmaceutical/biotech manufacturing
• Knowledge of FDA regulations and ICH Guidelines
• Strong interpersonal and communication skills
• Experience with Veeva Quality/Docs and QMS
• Ability to make compliant, risk-based decisions
• Detail-oriented and hands-on approach
• Ability to work with external suppliers
• Collaborative mindset

Benefits

• Base salary and equity opportunities
• Comprehensive benefits package
• Flexible paid time off
• Medical, dental, and vision insurance
• 401(k) offerings with employer match
• Mental health benefits through Employee Assistance Program
• Additional voluntary benefits
• Commitment to reasonable accommodations for disabilities
• Equal Opportunity Employer
• Ongoing candidate support and recruitment process