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System Analyst II

United States - California - Santa MonicaQualityRegular

Descripción del trabajo

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