CellCarta

Manager

• Lead and support the development and sustainability of CellCarta’s Quality Management System (QMS)
• Harmonize quality procedures and processes
• Provide quality data for the Corporate Quality Management Review
• Support proposal development
• Develop and improve harmonized policies, procedures, and work instructions to meet site and business needs and comply with external requirements
• Establish reports to gather and analyze quality data for Corporate Management Review
• Coordinate document control, including revisions, training assignments, and issuance of corporate procedures and policies
• Support the Supplier Quality Program by classifying and qualifying suppliers, auditing suppliers, maintaining quality agreements, serving as primary interface with corporate suppliers, maintaining SCAR systems, and maintaining the global approved supplier list and audit schedule
• Develop and execute an IT third-party vendor management program
• Support software development projects throughout the SDLC, including planning, requirements, risk management, design, verification, validation, release, and change management
• Participate in ISO certification audits, including ISO-27001 and ISO13485
• Serve as a subject matter expert on Quality Management Systems

Manager, Quality Management System, Supplier Quality

• Lead and support the development and sustainability of CellCarta’s Quality Management System
• Harmonize quality procedures and processes
• Provide quality data for the Corporate Quality Management Review
• Develop and improve policies, procedures, and work instructions
• Establish reports to gather and analyze quality data
• Coordinate document control, including revisions, training assignments, and issuance of corporate procedures and policies
• Support the Supplier Quality Program by classifying and qualifying suppliers
• Audit suppliers and maintain quality agreements with corporate suppliers
• Serve as the primary interface with corporate suppliers
• Maintain the Supplier Corrective Action Request (SCAR) system
• Maintain the global approved supplier list and audit schedule
• Develop and execute an IT third-party vendor management program
• Support software development projects throughout the software development lifecycle, including planning, requirements, risk management, design, verification, validation, release, and change management
• Participate in ISO certification audits, including ISO-27001 and ISO13485
• Serve as a subject matter expert on Quality Management Systems
• Support proposal development while collaborating with cross-functional professionals

Scientist

• Manage, plan, and execute complex technical and laboratory studies
• Write protocols and review and approve documentation in accordance with design control procedures
• Perform laboratory activities supporting assay development, validation, and implementation across multiple workflows
• Troubleshoot, interpret, and analyze data
• Evaluate and document studies and present results in technical reports
• Collaborate with internal teams and cross-functional stakeholders to deliver projects safely, efficiently, and in compliance with quality and regulatory requirements
• Prepare and present scientific data for internal and external projects
• Organize, lead, and participate in departmental and client meetings
• Develop, validate, and implement qPCR, dPCR, and NGS assays for clinical trials using RNA and DNA technologies

Manager, Quality Management System, Supplier Quality

Manager, Quality Management System, Supplier Quality

Assay Development Scientist – Genomics Services