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Quality Systems Associate - $8,000* Sign On

United States - California - El SegundoQualityRegular

Job Description

Kite is seeking a highly motivated individual to join us as a Quality Systems Associate.  This position will report into the Manager, QA Compliance and be located at the El Segundo, CA site.

Responsibilities include:

  • Support internal audits ensuring compliance of site processes and systems to FDA, EU and ROW regulatory requirements.
  • Publish and maintain metrics that measure the health and effectiveness of the audit program
  • Participate in the implementation and maintenance of procedures to assist in the execution of the site audit program.  
  • Assist in development of effective auditing tools and training aids  
  • Execute site area walk through program to ensure compliance and inspection readiness of site at all time.
  • Support site inspection readiness and inspection management programs.
  • Coordinate all aspects of inspection logistics at the site and support development of training aids on specific roles, responsibilities, processes and systems associated with inspection management and support.
  • Support management of writing and on-time completion of regulatory commitments, responses and other correspondence.
  • Coordinate and assist with key Quality Systems & Compliance meetings.
  • Identify compliance risks and escalate issues to appropriate levels of management for resolution. 
  • Identify and drive program improvements. 

Basic Qualifications:

  • Bachelor’s Degree and OR
  • AA Degree and 2+ years’ experience in GMP environment or related field OR
  • High School Degree and 3+ years’ experience in GMP environment or related field

Preferred Qualifications:

  • Demonstrates excellent organization skills and ability to work on specified projects with tight timelines.
  • Demonstrates excellent attention to detail.
  • Demonstrates excellent verbal, written and interpersonal skills.
  • Demonstrates a working understanding of compliance requirements.
  • Knowledge of GMPs, FDA, EU and ROW regulatory requirements.
  • Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205. 210, 211, 600, 610, 820; ATMPs; and Health Canada R.S.C., 1985, F-27, Section 30; as well as ICH, ISO and USP / EP compendial standards and principals.
  • Auditing experience and ability to perform on-site as well as investigative audits, ASQ Certification a plus.
  • Knowledge of the regulatory requirements related to Cell Therapy, Biologics and pharmaceuticals
  • Practical understanding of current GMP and GDP concepts and industry practices. 
  • Experience preparing for regulatory inspections and external audits.

Does this sound like you? If so, apply now!

*This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.