Job Description

The Senior QTC Analyst is responsible for overseeing daily operations to ensure compliance with regulatory agencies and Endpoint's Quality Management System (QMS) for product release launch activities and post-launch compliance. This role involves leading improvement projects, providing guidance, and acting as a subject matter expert.

Responsibilities

• Provide resourcing and guidance to the product release team
• Review and approve in-process tasks
• Develop and oversee onboarding and training of Analysts
• Act as a subject matter expert for the Software Development Life Cycle
• Develop and revise Validation Deliverables
• Provide training on compliance procedures
• Generate and maintain Validation Deliverables documentation
• Maintain validation documentation in QMS
• Support Operations staff with Validation Deliverables
• Act as primary QTC representative
• Assist in preparation of reports for product events
• Participate in Root Cause Analysis meetings
• Support CAPA team
• Support Governance unit during External Audits
• Perform QMS documentation Quality Control reviews

Requirements

• M.S. degree with 2+ years of experience OR BS/BA degree with 4+ years of experience
• Certification in Quality Assurance or Regulatory Affairs preferred
• 2-4 years of experience in a regulated environment
• Knowledge of FDA regulations (21 CFR Part 11, EU Annex 11)
• Knowledge of U.S. and international regulatory standards
• Experience in clinical trial industry, IRT, or CRO preferred
• Experience with a QMS and LMS preferred
• Strong communication, organizational, and interpersonal skills
• Strong decision-making and project management skills
• Proficiency in Microsoft Office applications and Adobe Acrobat Professional

Benefits

• No benefits