QA Specialist I (El Segundo) job in El Segundo, USA

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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Quality Assurance Specialist I position with an international biopharmaceutical company located in El Segundo, CA.

Job 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 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

To Apply:

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.

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