Senior Quality Control Specialist - Lean Lab Lead

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Jul 02, 2019
Ref
R0008360
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Kite is seeking a highly-motivated individual to join us as a Senior Specialist in the Quality Control (QC) team. You will work within the commercial QC organization as the lead for establishment and implementation of Lean Laboratory processes and culture. You will also have cross-functional interaction with personnel from other QC functions and sites, Quality Assurance, Manufacturing and Corporate teams.

In this position, you will have an overall responsibility, among others, of providing leadership and expertise for Lean Lab establishment, supporting implementation of Lean and Operational Excellence tools within the QC function, and providing mentorship of staff around Lean Lab concepts. Additionally, you will provide project and program management for all internal QC projects.

Key Responsibilities include (but are not limited to):
  • Provide technical leadership, mentoring, and project support as required to help support Lean Six Sigma initiatives.
  • Develop interdependent project plans in support of site activities, coordinating with other functions and sites to estimate resources and ensure deliverables
  • Coordinate project selection/stewardship and training activities
  • Participate as a member of the QC Leadership Team in the selection, development and execution of OE projects, strategic direction, prioritization, and communication
  • Help identify and achieve significant process/quality improvements through the OE initiatives
  • Expectation includes a hands-on teamwork approach to problems, planning, and people associated with all aspects of the initiatives
  • Work is performed without appreciable direction and exercises considerable latitude in the determining technical objectives of assignments
  • Provides guidance to customer, corporate and site team management based on organizational goals
  • Coordinate activities cross-functionally and across sites, when appropriate
  • Represents the organization as the main point of contact on programs and projects
  • Must demonstrate excellent communication skills, both verbal and written, and effective presentation skills communicating horizontally, vertically and throughout a matrixed organization
  • Work with laboratory supervisors to forecast demands related to their functional area, coordinate resources to ensure commitments are met
  • Initiates, coordinate and participates in multiple simultaneous projects that are complex and technically or operationally demanding
  • Training and mentoring for Lean Six Sigma White and Yellow Belt


Qualifications:
  • BA or BA with 7+ years or MS with 5+ years of experience in a GMP environment
  • Lean Six Sigma training/certification
  • Ability to independently lead work streams teams in support of projects
  • Ability to develop technical solutions to complex problems which require the regular use of ingenuity and creativity
  • Familiarity with FDA, ICH and GMP guidelines
  • Ability to think critically and demonstrate troubleshooting/problem solving skills
  • Excellent skills in Microsoft Office, data analysis software, and other related applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities


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Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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