Quality Systems Specialist I - $8,000* Sign OnUnited States - California - El SegundoQualityRegular
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.
We are seeking a highly motivated individual to join as a Quality Systems I located at Kite’s Commercial manufacturing site in El Segundo, CA. Reporting into the Quality Systems and Compliance Sr. Manager, you will provide oversight of Kite’s quality systems (Deviations, CAPA, EV, Change Control and Training).
- Establish and maintain a Deviation, CAPA, EV and Change Control Management System compliant with regulatory, quality, and Kite requirements.
- Provides guidance and advice on methods, procedures, standardization and requirements associated with these systems.
- Collaborates with cross-functional departments to ensure timely implementation of quality records.
- Support audits (internal, external) in order to verify that regulatory and quality requirements have been met.
- Support Deviation system and ensure proper investigation and root cause analysis are performed.
- Support CAPA/EV system to ensure proper corrective actions are implemented and effective.
- Support Change Control system to ensure proper change and impact assessments are performed and tasks are implemented.
- Develops, implements and delivers training content for Deviation, CAPA, EV and Change Control processes and procedures.
- Responsible for procedure reviews and facilitating procedure updates for the Deviation, CAPA, EV and Change Control systems.
- Assure that personnel are adequately trained in the principals, policies, and procedures of the Deviation, CAPA, EV and Change Control systems.
- Support tracking and communication of site metrics to management.
- Identify and escalate compliance gaps across quality systems.
- The standard work week for this position is Monday through Friday with occasional weekend work.
- Master’s Degree OR
- Bachelor’s Degree and 2+ years’ experience in a GMP environment OR
- AA Degree and 4+ years’ experience in a GMP environment OR
- High School Degree and 5+ years’ experience in a GMP environment
- Strong knowledge of GMP, SOPs and quality system processes.
- Excellent organizational skills and ability to review and update processes or procedures.
- Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems.
- Strong written and verbal communication skills.
- Experience in pharmaceutical or bio-pharmaceutical field.
- Education or training in cell culture and gene therapy manufacturing environment a plus.
- Proficient in drafting and completing technical documents and presentations.
- Expertise in document management processes.
- Works on multiple assignments in collaboration with various department system owners.
- Quality systems demonstrated knowledge in areas such as Deviation, CAPA, EV and Change Control system management practices/strategies.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
- Demonstrates basic understanding of training, instructional design, communication and/or education.
- Demonstrates knowledge and understanding of pharmaceutical manufacturing and quality assurance, aseptic and packaging processes and product transfer.
- Demonstrates functional and process knowledge to support the integrated design and development of training programs.
- Demonstrates ability to administer electronic Learning Management Systems (LMS).
- Demonstrates presentation skills with the ability to conduct training sessions.
- Proven organizational skills, planning skills and ability to work effectively within teams.
- Demonstrates ability to lead cross-functional project teams.
*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.