Scientific.
Clinical.
Software Engineering
Job Description
Position Summary:
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
Requirements:
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
PREFERRED REQUIREMENTS:
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
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