Senior QA Specialist, QA Operations

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Sep 11, 2020
Ref
R0013737
Required Education
Bachelors Degree
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

Kite is seeking a highly motivated individual to join us as a Senior QA Specialist. This position is responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. You will be located at our El Segundo, CA site and report into the Front Line QA arm of Quality Operations.

Responsibilities include (but are not limited to):
  • Work with Manufacturing Department as a production area Quality Assurance (QA) representative
  • Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
  • Provide quality assurance support resolving in-process product, final product, environmental, facility and equipment manufacturing issues
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Review batch-related documentation, and ensure resolution of issues to ensure timely disposition of product
  • Release media or other subassemblies to Production
  • Communicate lot disposition pending issues to Management
  • Identify compliance risks and escalate the issues to appropriate levels of management for resolution
  • Generate and update standard operating procedures and forms as needed
  • Provide training and support on-boarding of new QA staff
  • Review and approve manufacturing procedures
  • Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
  • Maintain metrics related to QA Operations activities
  • Represent QA Operations in various Site projects and initiatives
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
  • Provide QA oversight of Facilities and warehouse (as a back-up to main QA responsible)
  • Perform quality review and/or investigations of manufacturing deviations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed
  • Review and approve validation-related documents, as needed
  • Perform other duties as required to fulfill department and business needs
  • This position requires extended period of working in a standing position in a classified room environment.
  • This position requires working one day on weekends. Typical schedule is either Sunday through Thursday or Tuesday through Saturday.
  • Shift schedule: (Day Shift) 6:00 AM - 3:00 PM, (Swing Shift) 2:00 PM - 11:00 PM.
  • Work days, shift and working hours may change to meet the needs of the department and the needs of the business, in general.


Requirements:
  • Bachelor's degree in the biological sciences or related field with 7 years of experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience
  • Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
  • Ability to effectively negotiate and build collaboration amongst individuals
  • Good interpersonal, verbal and written communication skills
  • Ability to communicate and work independently with scientific/technical personnel.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
  • Strong decision-making skills
  • Experience with manufacturing investigations, deviations, and CAPA
  • Experience with change control practices and strategies
  • Experience with internal and external audits
  • Working knowledge of aseptic manufacturing processes
  • Knowledge of equipment, facility, and utility IQ/OQ/PQ
  • Proficient in MS Word, Excel, Power Point and other applications
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description


Preferred Qualifications:
  • Experience with information system development and implementation (e.g., electronic batch record, Oracle AGILE, Oracle EBS)
  • Experience with Cell & Gene Therapy Products or Blood and Blood Products
  • Experience presenting and responding to regulatory agency audits


#LI-MY1
#IND123

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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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.