Senior QA Specialist

Full-time Other-General

We are seeking a senior QA specialist who will play a critical role in driving compliance and quality across the organization’s biometric services and computer systems. This role involves hands-on execution of QA activities, leadership in audits and risk management, and close collaboration with cross-functional teams such as data management, biostatistics, statistical programming, software development and validation, and IT and security. 

The senior QA specialist will ensure that processes, computer systems, and deliverables adhere to GxP, ICH-GCP, 21 CFR Part 11, and other applicable regulations, as well as internal quality standards through proactive oversight, documentation review, system validation, and continuous process improvement. 

Essential Functions and Responsibilities 

1. Document & Process Auditing 

• Conduct and/or host internal audits and vendor audits 
• Review and audit Trial Master File (TMF) for completenes...