Document Control Analyst jobs in Oakland, CA

Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune diseases. The Kyverna therapeutic platform combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated.

Kyverna is recruiting a highly motivated Quality Assurance Associate, Document Control in its Technical Operations organization to help advance its mission to free patients from the siege of autoimmune disease.  The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: Bring Intellectual Rigor, Elevate Each Other, and Stay True To Why.   

The QA Associate, Document Control will be responsible for maintaining the document control process at Kyverna. This position will work with all Departments within Kyverna, to ensure consistent standards and requirements for document management are implemented consistently and to ensure international requirements are incorporated into the overall documentation program. 

• Support the operation of Kyverna's electronic Quality Management System (QMS), with a focus on Document Control
• Serve as the Subject Matter Expert in the Document Control workflow, including end user training and support within the greater Kyverna organizaton.
• Generate and maintain master templates for various GxP document types.
• Maintain compliance with good documentation practices for all GxP records
• Ensure compliance with controlled document formats and content. 
• Ensure documents and records (both hardcopy and electronic) are maintained per document retention policies, are retrievable, and files are accurate, complete, and well-organized. 
• Support issuance of controlled documents such as forms, checklists, etc.  
• Support assignment of the appropriate training requirements for documentation within the eQMS. 
• Maintain metrics/reports of Document Control workflow status and periodic document review status. 
• Other duties as assigned.

• Bachelor’s degree in science or engineering discipline with 3 years experience working in a GxP Document Control or Quality Systems function. 
• Experience working with electronic Quality/Document Management System required. 
• Prior experience with electronic signature platforms preferred. 
• Independently motivated, detail oriented and good problem-solving ability. 
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders. 
• Excellent verbal, written and presentation skills and effectively communicate with all levels of management. 
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. 
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments. 
• Self-starter, works effectively in teams. 

The salary range for this position is $90,000 USD to $115,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock option plan. 

(Position is commensurate with the experience of the successful candidate.) 

Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets