QA Operations Specialist I - $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 QA Specialist I to join our team at our El Segundo, CA facility.

Responsibilities (included but not limited to):

• ​Perform receipt and disposition of incoming apheresis material.
• Perform verification/inspection and ensure timely issuance of production documents and labels
• Perform shipment authorization
• Perform incoming label inspection
• Review batch-related documentation, and ensure resolution of issues to release and ship product.
• Ensure timely resolution and escalation of issues in operations
• Ensure all product-related Deviations are initiated, investigated and resolved.
• Ensure that associated CAPAs are initiated and resolved, as needed.
• Ensure approval and timely delivery of final product.
• 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.
• Gather metric information for use in continuous improvement of areas of responsibility.
• Maintain/Update huddle board tracker, deviation tracking log, task tracker and issue monthly reports.
• Maintain department training tracker.
• Execute UAT testing when required.

Basic Qualifications:

• Master’s Degree and OR

• Bachelor’s Degree and 2+ years’ experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR
• AA Degree and 4+ years’ experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR
• High School Degree and 5+ years’ experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

Preferred Qualifications:

• Works on multiple assignments in collaborative and dynamic environment.
• 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, Power Point and other applications.
• Strong interpersonal, verbal and written communication skills
• Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities

Does this sound like you? If so, apply today!

* 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.