System Analyst II

Job Description

Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.

Responsibilities

• Work collaboratively with Quality, Manufacturing, Laboratory Information Management System (LIMS) Administrators, Developers, Vendors and Information Technology (IT) to meet project deliverables and timelines
• Interact with the laboratory operations group to support LIMS implementation and ongoing support for new module implementations and/or installation of new capabilities
• Work with the IT groups to integrate LIMS in a current Good Manufacturing Practice (cGMP) environment.
• Partner with IT and laboratory organizations to support user change requests and training needs
• Comply with Software Development Lifecycle and company’s Computer Systems Validation (CSV) process and procedures
• Work collaboratively to analyze complex master data and custom configuration in LIMS system
• Actively participate in all phases of application implementation, including ownership of key deliverables such as
• User Requirements Specifications
• Function Specification
• Design Specifications
• User acceptance testing
• Validation documentation
• Deployment & Hypercare support
• Assist in developing Standard Operating Procedures (SOPs) for global and local LIMS
• Identify and recommend areas of process improvement
• Perform knowledge transfer and provide ongoing leadership, to support project go-live and beyond, operations and support activities

Basic Qualifications

• Master’s Degree and 2 years of life science business process analysis and information systems project support experience OR
• Bachelor’s Degree and 4 years of life science business process analysis and information systems project support experience OR
• AA Degree and 5 years of life science business process analysis and information systems project support experience OR
• High School Degree and 6 years of life science business process analysis and information systems project support experience

Preferred Qualifications

• Excellent technical writing experience in a regulatory environment, including experience in writing detailed SOPs, requirements, user stories, business processes, technical specifications, test protocols and reports, for both custom and commercial off-the-shelf (COTS) systems
• Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance.
• Familiarity with Computer Systems Validation (CSV) and GxP processes
• General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations
• Excellent interpersonal, verbal and written communication skills including facilitating group discussions and clarifying requirements
• Comfortable in a fast-paced growing company with minimal direction and able to adjust workload based upon changing priorities
• Ability to work occasional off hours as needed
• Ability to travel and work at multiple locations (Southern CA: ~10%; Other: ~5%)
• Biotech/Life Science industry experience
• LabVantage LIMS
• Biopharma manufacturing environment
• Supporting a multi-site enterprise system with master data (LIMS, MES, PLM)
• Familiarity with analytical methods such as Cell Based Assays, Binding Assays, Microbiological assays, HPLC, ELISA and other routine analytical assays
• Ability to demonstrate critical thinking