Quality Control Operations Specialist (Quality Records) - $8,000* Sign On

Job Description

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. Join us in our mission!

Kite is seeking a highly-motivated individual to join us as a Quality Control Operations Specialist I in the Commercial Quality Control (QC) organization. You will work directly with the analytical QC testing function and will have cross-functional interaction with personnel from other Quality groups, Quality Assurance, Analytical Development, Manufacturing and Corporate teams.

Working Hours: Wednesday through Saturday, 9:30 a.m.- 8:30 p.m. with some flexibility with starting and end times, the position will provide support for both a.m. and swing shift.

Responsibilities:

• Own and manage different AGILE records (CAPA, Deviation, LIR)
• Support investigations regarding out of specification (OOS) results, Out of Trend (OOT) events and any other unexpected event related to the laboratory
• Troubleshoot standard issues and identify when a deviation from standard process occurs
• Manage issue escalations and subsequent notifications in appropriate portals
• Develop, revise and review SOPs and Work Instructions
• Work with internal resources to maintain lab in an optimal state
• Evaluate current operational processes and practices for efficiency and potential improvements. Report and develop action plans to implement findings
• Organize and execute multiple projects in a collaborative team environment
• Provide compliance and technical knowledge as needed
• Monitor the GMP systems currently in place to ensure compliance with documented policies
• Gather metric information for use in continuous improvement of areas of responsibility
• Monitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release
• Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies
• Perform activities around scanning and archiving documents for the site

Basic Qualifications:

• Master’s Degree OR
• Bachelor’s Degree and 2+ years’ experience in the biotech/biopharmaceutical setting OR
• AA Degree and 4+ years’ experience in the biotech/biopharmaceutical setting OR
• High School Degree and 5+ years’ experience in the biotech/biopharmaceutical setting

Preferred Qualifications:

• Familiar with analyzing and reporting results and metrics using graphical presentation
• 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
• Strong technical writing ability
• Proficient in advanced investigational and root cause analysis tools
• Proficient in MS Word, Excel, Power Point and other applications
• Excellent interpersonal, verbal and written communication skills

*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.

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