Quality Assurance Operations Specialist - $8,000* Sign OnUnited States - California - El SegundoQualityRegular
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.
- 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
- 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
- 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.