United States onlyKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what's possible.
Position Summary
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.
Title: Specialist, Document Management & Training (Contract)
Reports to: Sr. Specialist, Document Management & Training
Location: Remote
Travel: None
Duration: 6+ Months
Hourly Rate: $50–$60/hour
Responsibilities
- 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. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements.
- 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.
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.
