Quality Systems Specialist III美国 - 加利福尼亚州 - 圣莫尼卡质量正式员工
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.
Kite is seeking a highly motivated individual to join us as a Quality Systems Specialist III in our clinical cell therapy production center located in Santa Monica CA. The Quality Systems Specialist III will be responsible for providing support of clinical manufacturing. In this role you will be responsible for technical oversight of Quality Systems and programs for cell therapy products. You will report to the Associate Director Quality Systems and Compliance.
Responsibilities (include but are not limited to):
- Perform document control activities including issuance and verification of manufacturing lots
- Perform all activities around scanning and archiving documents for the site
- Represent the group at network and global meetings
- Investigate and manage deviations related to quality systems. Determine corrective/preventative actions (CAPA) and drive implementation.
- Provide ILT trainings on GDP and provide trainings as required
- Be an advocate on the new phase appropriate approach of manufacturing at the clinical site
- Generate data reports as required to be presented at Tier 4 and 5 meetings and at QMRs
- Provide Quality Systems activities and provide technical direction as needed
- Develop, revise and review SOPs and Work Instructions
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
- Gather metric information for use in continuous improvement of areas of responsibility
- Respond to site training needs and work with the team to address these concerns
- Work close with the audit team and facilitate risk assessments for the site as needed
- Perform other duties as assigned
- Master’s Degree and 3+ years’ experience in Quality OR
- Bachelor’s Degree and 5+ years’ experience in Quality OR
- High School Degree and 9+ years’ experience in Quality
- The ideal candidate is familiar with analyzing and reporting results and metrics using graphical presentation.
- The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- Strong knowledge of GMP, SOPs and quality control processes.
- Strong data integrity knowledge and practices.
- Identifying, writing evaluating and closing OOS’s and investigations.
- Proficient in MS Word, Excel, Power Point and other applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.