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Becomes a resource fluent in aseptic cell culture manufacturing and provides consultation on quality considerations related to aseptic biotechnology manufacturing. Astellas is announcing a Quality Systems Engineer opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA. Purpose:The Quality Systems Engineer role participates in the development and execution of key compliance functions within the larger GMP Quality Assurance department.
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About Tenet Massachusetts Facilities: Saint Vincent Hospital – Worcester, MA MetroWest Medical Center – Framingham, MA Leonard Morse Hospital – Natick, MA (part of MWMC) MA - SVH Tenet’s Saint Vincent Hospital has been providing high-quality health care to Worcester and the surrounding communities for more than 125 years.
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Display understanding of Downstream process theory (e.g., tangential flow filtration, chromatography) equipment operation, and aseptic processing. Experience in cell culture with excellent aseptic technique.
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Must have knowledge of aseptic technique, environmental monitoring, and microbiological Quality Control testing and procedures. Perform laboratory analysis of samples, using aseptic technique, following established.
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788 microscopy method, Bioburden, BET, environmental monitoring, water testing, compressed gas testing). Associates degree in Biological Sciences or related field, plus three (3) or more years of QC microbiology laboratory experience with minimum of one (1) year performing viable and non-viable sampling in an ISO classified cleanroom.
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Operates and maintains laboratory instruments, while ensuring the reliability of instrumentation. Has ability to complete sampling or testing assignments in a timely and compliant manner, with minimal supervision as well as being able to learn and execute other tasks as needed.
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Responsible for Patient Safety, including pre-screening for contra-indications, aseptic injection technique and may require remote MR Technologists Assistant oversite. MRI, MRI Technologist, MRI Tech, ARRT, radiology, magnetic resonance imaging, magnetic resonance, diagnostic imaging, diagnostic, imaging, diagnostic scan, diagnostic scanning, MRI scanner, MRI scan, technologist, health care, healthcare.
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Any candidates that have a chemistry or microbiology background as product is chemical detergent, and or pharmaceuticals, sterile aseptic, injectables. Equipment cleaned are stainless steel bioreactors, media fill vessels, upstream/downstream equipment, chromatography.
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