Senti is a technology-driven therapeutics company here to lead the next generation of medicine—where cells are the hardware and gene circuits are the software. Programming cells to respond, adapt and make decisions, Senti is working to create smarter therapies with computer-like logic, enhanced functionality and greater control.
- Manage document control lifecycle and support daily activities that includes but not limited to document numbering, routing for review/approval, filing, tracking, and monitor of periodic review process. Support authoring QMS SOPs, as needed.
- Manage implementation and monitoring of training curriculum for employees across the organization. Create training e-folders for employees and track and report training status as required.
- Provide quality training for new hires and support ongoing GxP training as needed.
- Implement and Monitor performance metrics and continuous improvements of internal quality processes.
- Manage contract service providers (CSPs) that includes but not limited to follow up on audit outcomes, update the tracking list of CSPs, plan for periodic routine audits, and audit planning.
- Compile, organize, and file documents (hard copy & e-copies).
- Support document review, as needed.
- Undergraduate or graduate degree in Biological or science major .
- 4-6 years of Quality Assurance experience within pharmaceutical and/or biotechnology company. Strong knowledge of GLP, GMP, and GCP is required.
- Strong understanding of Quality best practices, including familiarity with Quality System Regulations, GxPs and applicable ISO standards.
- Work experience with different computerized systems and software such as MS Office skills (Word, Excel, Power point), Google Drive, and eQMS.
- Demonstrate ability to work independently with scientific/technical personnel.
- Excellent interpersonal skills, including listening, writing, facilitations, attention to detail.
- Have excellent organizational skills, multitasking, and decisiveness.
- Ability to effectively collaborate in a dynamic environment.