Quality Assurance Specialist III

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Sep 11, 2019
Ref
R0008983
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a highly motivated individual to join us as a Quality Assurance Specialist III at the commercial manufacturing site in El Segundo. You will report into the Front Line QA Team of QA Operations. In this role, you will ensure quality product and timely delivery - every patient, every time.

Core Responsibilities (include but are not limited to):
  • Work with Manufacturing Department and Materials Management Department as area Quality Assurance (QA) representative
  • Provide quality assurance input and oversight in resolving manufacturing and warehouse operations-related issues
  • Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
  • Perform walk-throughs and process observations
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Review batch-related documentation, and ensure resolution of issues to ensure timely release of final product
  • Escalate issues that may adversely impact timely release of product
  • Identify compliance risks and escalate the issues to appropriate levels of management for resolution
  • Generate and update procedures and forms as needed


Additional Responsibilities
  • Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
  • Maintain metrics related to QA Operations activities
  • Provide QA oversight for the for the following: review and approval of deviations, CAPAs and change records
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
  • May oversee the packaging and shipping process, and perform shipment authorization
  • May perform disposition of incoming materials, components, and labels for GMP use
  • Perform final product visual inspection
  • Perform other duties as required


Requirements:
  • Bachelor's degree in the biological sciences or related field and minimum of 5-6 years progressive experience in a pharmaceutical, biotechnology, 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
  • Experience with investigations, deviations, and CAPA
  • Experience with internal and external audits
  • General knowledge of aseptic manufacturing processes
  • Knowledge change control and validation principles
  • Proficient in MS Word, Excel, Power Point and other applications
  • Available to work on weekends (Saturday or Sunday), certain holidays and/or swing shift schedule

Preferred Qualifications:
  • Experience with warehouse operations either in Materials Management or QA role
  • Experience in both clinical and commercial manufacturing environment
  • Experience with Cellular & Gene Therapy Products, blood and blood product or biologics
  • Experience presenting and responding to regulatory agency audits
  • Experience with MES/Electronic Batch Record
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description


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.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

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