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Quality Assurance Documentation Lead

United States - California - El SegundoQualityRegular

Job Description

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

Responsibilities:

  • Serving as a working lead, leading a team of high-performing individuals, including organizing/ prioritizing workflow, daily tasks, scheduling and individual development in support of greater team achievement
  • Driving a culture of Operational Excellence in the group and a hands-on, team-oriented approach to problem-solving, planning, and people-management
  • Attending cross functional daily meetings (3 PAR), department weekly meetings and serving as POC for urgent / escalated issues, reporting and escalating any issues to Senior Manager
  • Coordinating and resolving equipment issues in a timely manner
  • Working cross functionally with Materials Management and Supply Chain to coordinate the implementation and obsolescence of final product labels related to product launches, change control tasks and expiry
  • Ensuring timely distribution of controlled issued documentation to operational departments
  • Providing support to internal and regulatory audits/inspections
  • Ensuring compliance with global Good Manufacturing Practices, internal procedures, policies, and regulatory requirements, and RTF initiatives
  • Writing and revising standard operating procedures (SOPs) and work instructions for continuous improvement of systems.
  • Ensuring quality of on-the-job trainings and provides hands-on day-to-day guidance to the personnel
  • Ensuring inventory of operational materials are maintained and sourced
  • Maintaining/presenting monthly document control metrics and support weekly department meetings
  • Ensuring regular 1:1, employee feedback, midyear and end of year check ins, including coaching and disciplinary actions as appropriate and supporting employee recognition programs
  • Creating, maintaining, and contributing to continuous improvement of document issuance operation
  • Support the coordination and timely execution of test scripts, dry runs, engineering runs and UAT testing

Basic Qualifications:

  • Master's Degree and 3+ years of experience OR
  • Bachelor’s Degree and 5+ years of experience OR
  • High School Degree and 9+ years’ experience

Preferred Qualifications:

  • 6+ years’ experience in the pharmaceutical industry and 2+ years of Document Control or Quality Assurance, or Quality Systems
  • Knowledgeable of industry documentation types and Good Documentation Practices (GDP)
  • Strong knowledge of Document Control fundamentals
  • Previous experience within cell therapy
  • Excellent word processing and verbal and written communication skills
  • Working knowledge of Electronic Document Management Systems (EDMS)
  • Ability to apply knowledge of current Good Manufacturing Practices (GMP)
  • Direct experience maintaining procedures as they relate to the FDA Quality System regulations and EU, CA, AU regulations
  • Demonstrate advanced knowledge of computer systems which support document control processes and Proficiency in Microsoft Office, Excel, as well as exposure to technical document source applications such as Adobe Acrobat
  • Demonstrate an ability and desiring to supervise and support staff
  • Demonstrate Ability to multitask, prioritize and meet deadlines
  • Proficiency in analytical problem-solving skills