Lab Operations Specialist II - Sample Management

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.

We are seeking a highly motivated individual to join us as a Lab Ops Specialist II in Quality Control Sample Management in Santa Monica, CA.

Responsibilities

• Perform QC sample receipt, processing and distribution for testing and storage
• Perform Apheresis Accession, Inspection, and assist QA with product returns
• Maintain, operate equipment and instruments supporting sample processing
• Work with internal resources to maintain lab in an optimal state
• Perform Cryo sample disposition and shipment
• Track inventory of lab supplies and materials
• Track inventory of retain samples, stability samples, test materials
• Track and distribute samples according to Stability protocols
• Support on-the job training for junior staff
• Troubleshoot standard issues and identify when a deviation from standard process occurs
• Own deviations, CAPAs, change controls when necessary
• Gather metric information for use in continuous improvement of areas of responsibility
• Data entry and review
• Support generation of CoAs for product release
• Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies, if needed
• Develop, revise and review SOPs, work-instructions, forms, sampling plans, qualification/validation protocols and reports
• Support investigations regarding out of specification (OOS) results, Out of Trend (OOT) events and any other unexpected event related to the laboratory
• Monitor the GMP systems currently in place to ensure compliance with documented policies
• Evaluate current operational processes and practices for efficiency and potential improvements
• Work with LIMS administrators to incorporate new processes for sample management in LIMS
• Assist with audits, walkthroughs, inspections, when necessary
• Additional duties as assigned
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed

Basic Qualifications

Master’s Degree

OR

Bachelor’s Degree and 2+ years of experience in Quality Control/GMP Environment

OR

Associate Degree and 4+ years of experience in Quality Control/GMP Environment

OR

High School Degree and 5+ years of experience in Quality Control/GMP Environment

Preferred Qualifications

• Degree in biotechnology or related field with Quality Control experience
• Working knowledge of GMP, SOPs and quality control processes
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
• Proficient in MS Word, Excel, Power Point and other applications
• Ability to communicate and work independently with scientific/technical personnel
• Strong written and verbal communication skills
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Experience with LabVantage LIMS
• Ability to work with a variable schedule

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