Job Title: QA Specialist I - QA Operations
Duration: 6 months contract
Location: El Segundo, CA
QA Specialist I - QA Operations (CW)
This position requires working one day on weekends.
Typical schedule is either Sunday through Thursday or Tuesday through Saturday.
Shift schedule: (Day Shift) 6:00 AM – 3:00 PM, (Swing Shift) 2:00 PM – 11:00 PM.
Work days, shift and working hours may change to meet the needs of the department and the needs of the business, in general.
Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
Provide Quality Assurance support involving manufacturing production issues
Ensure that Kite products are manufactured in compliance with site, regulatory and GMP guidelines Ensure timely issuance of production records and labels
Elevate issues affecting lot production or release to Management in a timely manner
Ensure approval and timely delivery of Final Product
Review and approve executed Manufacturing Production Records for regulatory and Kite compliance
Compile and verify all batch-related documents into a Final Product lot disposition package
Perform quality review and/or investigations of manufacturing deviations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed
Gather metric information for use in continuous improvement of areas of responsibility, as needed
Perform other duties as required to fulfill department and business needs
Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 2-4 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
Working knowledge of GMP, quality systems and regulatory requirements (21 CRF Part 11/210/211/600/610), practices/principles
Knowledge of relevant ICH and FDA guidance documents
Experience in identifying deviations and CAPA
General knowledge of aseptic manufacturing processes
Proficient in MS Word, Excel, Power Point and other applications
Strong written and verbal communication skills
Ability to communicate and work independently with scientific/technical personnel
Experience with cell therapy manufacturing
Experience with internal and external audit
Experience in warehouse management
Experience with Health Authority Regulations and Validation practices/principles
Experience in working directly as QA or principal for Facilities and Engineering
Knowledge of IQ/OQ/PQ