Us Citizen
Green Card
EAD (OPT/CPT/GC/H4)
H1B Work Permit
Corp-Corp
Consulting/Contract
UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 6th Aug 2021
• 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 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
REQUIREMENTS:
• 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 CFR Part 11/210/211/600/610), practices/principles
• Knowledge of relevant ICH and FDA guidance documents and
• Experience in identifying deviations and CAPA
• General knowledge of aseptic manufacturing processes
• Proficient in MS Word, Excel, PowerPoint and other applications
• Strong written and verbal communication skills
• Ability to communicate and work independently with scientific/technical personnel
PREFERRED REQUIREMENTS:
• Experience with cell therapy manufacturing
• ASQ certification(s)
• Experience with internal and external audit
• Experience with Health Authority Regulations and Validation practices/principles
• Knowledge of IQ/OQ/PQ