QA Documentation Specialist I

QA Documentation Specialist at Kite Pharma responsible for managing document control processes, maintaining GMP compliance, and supporting quality systems within a cancer immunotherapy company. Position requires pharmaceutical industry experience and proficiency with electronic document management systems.

Responsibilities

• Ensure timely implementation of Change Requests, Document Change Orders, and documentation updates
• Maintain accuracy of documentation manuals and database entries with verification of own work
• Support distribution and maintenance of GXP documentation; scan, verify, and archive as needed
• Provide user training for electronic systems and create document templates
• Support internal and regulatory audits, recommend process improvements, and maintain control metrics

Requirements

• 5+ years pharmaceutical industry experience with high school diploma, or 3+ years with associate degree
• Advanced knowledge of document control, quality systems, and GMP requirements
• Working knowledge of Electronic Document Management Systems (EDMS)
• Proficiency in Microsoft Office and Oracle environments
• Strong verbal, written, and interpersonal communication skills
• Understanding of 21 CFR, GxP, ICH regulations and compliance requirements
• High attention to detail and problem-solving abilities

Compensation: $80,325.00 - $103,950.00 base