Orange County Metro Area,
Job Number: JN -082020-4505
Our client, a global life sciences organization, has an immediate need for a QA Specialist to join their team 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
- Bachelor s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 2 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
- 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.
Having been in business since 2006, Vivo is a full-service recruiting and consulting company, specializing in mid to senior level technology resources. Our brand promise is simple: we get people. We get that our clients don t want to waste time and that our candidates and employees thrive when given honest feedback and an opportunity to grow.
Whether you re onsite at our Pleasanton headquarters or working for one of Vivo s clients the best brand names out there our promise to you is unwavering: we will treat you like you are our most important employee.
Do you think you get people get what they really need, and get how to deliver? We re not perfect but we re accountable. We re not in 32 countries, but we are in the heart of it all. So, if you are looking for a flexible, fun and high-energy work environment, along with the opportunity to work with some of the world s technology leaders, we can t wait to talk to you.
Vivo We Get People!