[Hiring] Specialist, Document Management & Training @Kyverna Therapeutics

Role Description

The Specialist, Document Management & Training is responsible for supporting the administration and continuous improvement of the document control and training systems within a GMP-regulated environment. This role ensures that controlled documents and training records are accurate, compliant, and maintained in accordance with regulatory requirements and internal procedures. The Specialist will partner cross-functionally to manage document lifecycles, support training compliance, and drive timely completion of training assignments, while contributing to operational excellence and inspection readiness initiatives.

Qualifications

• Bachelor’s degree in Computer Science, Life Science or related field or applicable experience.
• 2+ years in Quality Systems/Quality Assurance experience in the regulated life sciences industry.
• Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
• Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience strongly desired.
• Experience with Dot Compliance, preferred.
• Experience developing improvements to electronic Quality Systems.
• Strong software proficiency with Microsoft Suite and other desktop applications.
• Ability to manage multiple projects in a dynamic environment with attention to detail.
• A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
• Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Requirements

• Support day-to-day Document Control and Training processes.
• Assist with the development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides.
• Execute against enterprise formatting/authoring standards and ensure all documentation is formatted accordingly.
• Track and drive timely periodic review and approval of documents.
• Create and maintain training requirements and training plans in the eLMS.
• Generate compliance metrics and prepare routine KPI reports for Document Control and Training processes.
• Ensure training compliance by monitoring completion of required training and following up with stakeholders as needed.
• Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other duties, as assigned.

Benefits

• Hourly Rate: $50–$60/hour
• Duration: 6+ Months
• Location: Remote
• Travel: None