Senior QA Specialist

EDETEK

1d • Remote

About The Position

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.

Requirements

• Ability to communicate effectively in English (spoken and written)
• Ability to work independently, take initiative, and meet deadlines
• Capable of prioritizing and executing tasks in a high-pressure environment
• Demonstrated collaboration skills across diverse teams and functions
• Adaptable and productive in a dynamic, evolving environment
• Proficiency with Microsoft Office applications
• Bachelor’s degree in life sciences, computer science, or a related field
• Minimum of 5 years of QA experience in clinical research, clinical systems, or regulated software environments
• Strong knowledge of GxP, ICH-GCP, 21 CFR Part 11, Annex 11, and SDLC principles
• Proven experience in conducting audits and managing CAPAs
• Excellent documentation and communication skills

Nice To Haves

• Experience in a company offering eClinical or biometric services
• Familiarity with electronic QMS platforms such as ZenQMS

Responsibilities

• Document & Process Auditing
• SOPs, Policies and QMS Maintenance
• Training Management
• Computer System Validation Support
• Audit and Inspection Readiness
• Cross-Functional Support
• Continuous Improvement

Benefits

• Choice of comprehensive Medical, Vision and Dental Insurance plans
• Paid vacation time and sick days
• Corporate holidays annually
• Participation in the 401K Plan
• Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.
• Health Advocate and Employee Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees