Quality Assurance Specialist

We 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 needs

Requirements

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 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