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 laboratoryTroubleshoot standard issues and identify when a deviation from standard process occursManage issue escalations and subsequent notifications in appropriate portalsDevelop, revise and review SOPs and Work InstructionsWork with internal resources to maintain lab in an optimal stateEvaluate current operational processes and practices for efficiency and potential improvements. Report and develop action plans to implement findingsOrganize and execute multiple projects in a collaborative team environmentProvide compliance and technical knowledge as neededMonitor the GMP systems currently in place to ensure compliance with documented policiesGather metric information for use in continuous improvement of areas of responsibilityMonitor and trend data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product releaseAssist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agenciesPerform activities around scanning and archiving documents for the site Basic Qualifications:Master’s Degree ORBachelor’s Degree and 2+ years’ experience in the biotech/biopharmaceutical setting ORAA Degree and 4+ years’ experience in the biotech/biopharmaceutical setting ORHigh School Degree and 5+ years’ experience in the biotech/biopharmaceutical settingPreferred Qualifications:Familiar with analyzing and reporting results and metrics using graphical presentationWorking knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)Strong knowledge of GMP, SOPs and quality control processesStrong data integrity knowledge and practicesStrong technical writing abilityProficient in advanced investigational and root cause analysis toolsProficient in MS Word, Excel, Power Point and other applicationsExcellent 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. #IND123#QCQA123