Quality Assurance Specialist -Gcp

A biotechnology client is looking for a Senior Quality Assurance Specialist , specifically with documentation experience in biotechnology or pharmaceutical industry

Job Overview

Senior QA Documentation Specialist, you will be instrumental in the management and evolution of the Veeva Learning Management System to meet the challenges of compliance in late-stage clinical drug product and commercial drug product. The Senior QA Documentation Specialist will be responsible for supporting the daily activities of Documentation Management. This role will act as interdepartmental liaison to various groups within Intellia as we support multi modalities within the cell and gene therapy space.

Job Functions: (Primary essential duties and responsibilities)

• Maintaining the Record Retention Schedule for GxP documents/records
• Providing day-to-day support of electronic document management system (Veeva Quality Vault: Quality Docs)
• Filing/Archiving GxP documents/records as required
• Developing, continuously improving, and implementing procedures related to Documentation Management.
• Assisting functional area management in driving timely completion of periodic reviews.

Required Knowledge, Skills and Abilities:

· Experience with Veeva Quality Vault: QualityDocs

· Strong MS Word skills

· Strong working knowledge of cGxPs and international regulatory requirements