QA Specialist I (El Segundo)
Proclinical is currently recruiting for a Quality Assurance Specialist I position with an international biopharmaceutical company located in El Segundo, CA.
- 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
Skills and 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 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
- ASQ certification(s)
- 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
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Thalheimer at (+1) 215-531-5299 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.