Quality Document Control Specialist
- 2200 Bridge Pkwy, Redwood City, CA 94065, USA
Jasper Therapeutics is a start-up company out of Stanford University with a lead clinical-stage program that is a first-in-class and potentially breakthrough antibody to safely replace chemo-radiation as a conditioning agent for diseases for which hematopoietic cell transplants (HCT) of allogeneic or gene-modified cells are the only known curative therapy. These diseases include but are not limited to rare genetic blood diseases such as the primary immune deficiency diseases, hemoglobinopathies, and myeloid disorders including myelodysplastic syndrome and acute myeloid leukemia. Additional potential indications include immune tolerance induction for the cure of autoimmune disorders and to facilitate acceptance of solid organ transplants. By creating novel, safe and highly effective conditioning regimens for hematopoietic transplantation, Jasper is leading the field with innovative clinical trials to safely bring cures to patients suffering from a variety of life-threatening diseases.
The Jasper vision is to build a leading biotechnology company to advance the field of hematopoietic cell transplantation by leveraging its basic and translational science to generate a pipeline of innovative therapeutics in the areas of HCT conditioning, immune modulation, cell engineering and gene editing therapies.
The Quality Document Control Specialist is a key implementor, archivist and quality trainer for individuals working within the Jasper Quality System. The Document Control Specialist is responsible for the implementation, record keeping, training and maintenance of all SOPs and supporting documents within the internal Quality System. This individual is comfortable working in a flexible environment and is successful working both remotely or on site.
· Maintain Quality Systems documentation
· Maintain in-house training programs, including training matrix, training files, issuance of training requests and audits of training files
· Work closely with external vendors, functional areas and Project Management team for daily management of routing, revisions, approval, and filing of documents within defined timelines
· Organize and ensure accurate and reliable filing systems for all electronic and paper-based GMP documents
· Manage the computer system account access log, file completed system account request form; work with IT to deactivate accounts on a quarterly basis.
· Route SOPs for annual review
· Other assigned QA/Regulatory tasks
· 1-3 years’ experience within a GXP quality system in the document control arena or equivalent experience
· BA/BS required; concentration in science or biotechnology desired
· Ability to work in a matrix team environment across all GXP environments
· Familiarity with documents and records associated with GxP manufacturing and testing activities
· Understanding of current regulatory expectations including 21CFR Part 11 requirements
· Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
· Strong attention to detail, organizational skills, ability to work in a faced paced environment
- High-science environment in a growing company with transformational science to cure devastating diseases
- Experienced, top-tier team invested in your long-term professional development
- Collaborative company culture with potential for broad exposure to the entire company
- Well-funded company with premier investors and public funding Validating collaborations with leading research centers and innovative gene therapy partnerships
- Competitive compensation and benefits
- Jasper Therapeutics is an equal opportunity employer
information will be kept confidential according to EEO guidelines.