Quality Assurance Specialist

Company: LanceSoft Inc
Location: El Segundo
Posted on: May 16, 2022

Job Description:

Job DescriptionWe are seeking a highly motivated individual for the role of Specialist I, QA Operations to work in this exciting new area of cancer immunotherapy. You will report into the Quality Records Team Manager of QA Operations and be based in our El Segundo site and associated clinical and commercial manufacturing and testing laboratories.RESPONSIBILITIES: 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 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 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 needsREQUIREMENTS: Bachelors 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 and 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 personnelPREFERRED 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

Keywords: LanceSoft Inc, Los Angeles , Quality Assurance Specialist, Other , El Segundo, California