Quality Systems Associate - $8,000* Sign OnUnited States - California - El SegundoQualityRegular
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.
- 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.
- 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
- 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.