Quality Assurance Operations Specialist - $8,000* Sign On

职位描述

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 QA Operations Specialist I for our commercial facility in El Segundo, CA site.

Shift schedule: (Graveyard Shift) 12:00 AM – 10:30 AM.  Typical schedule is Wednesday through Saturday.

Responsibilities:

• Perform receipt and disposition of incoming apheresis and frozen PBMC
• Perform verification of final product labels
• Perform shipment authorization
• Perform incoming label inspection
• Perform disposition of incoming labeling materials, as assigned
• Review batch-related documentation, and ensure resolution of issues to release and ship product
• Support and participate in timely resolution and escalation of accession related activity issues
• Initiate, investigate and resolve all product related deviations, as assigned
• Ensure that associated CAPAs are initiated and resolved, as assigned
• Ensure products are manufactured in compliance with regulatory and GMP guidelines
• Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues
• Maintain metrics related to accession activities in production schedule
• Support and participate in inspections and audits
• Works on multiple assignments in collaborative and dynamic environment

Basic Qualifications:

• Master’s Degree and OR
• Bachelor’s Degree and 2+ years’ experience OR
• AA Degree and 4+ years’ experience OR
• High School Degree and 5+ years’ experience

Preferred Qualifications:

• 3+ years’ experience in a in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
• Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Strong teamwork and collaborative skills
• Experience with manufacturing investigations, deviations, and CAPA
• Experience with change control practices and strategies
• General knowledge of aseptic manufacturing processes
• Proficient in MS Word, Excel, PowerPoint
• Strong 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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