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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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Pharmaceutical facilities including GMP - Aseptic and non-Aseptic Areas and Non GMP Areas. Assemble pipe sections, tubing or fittings using couplings, clamps, screws, bolts, cement, plastic solvent, caulking, soldering or brazing equipment.
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Works with materials that include carbon steel, stainless steel, plastics, fiberglass, copper, (brazed, soft soldered and pro-press); The Pipefitter will participate in the installation or maintenance and inspection of HVAC, Utility and Process piping systems.
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Expertise in aseptic processing and cell culture such as human Embryonic /Pluripotent Stem Cells or direct experience in cell culture manipulations related to cell product process development and/or manufacturing.
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Uses aseptic techniques or universal precautions as warranted or prudent, and disposes of hazardous waste in the proper manner. Ensures quality and safe delivery of care to patients in the following age groups: All ages; Neonate; Infancy; Toddler; Preschool; School age; Adolescent; Adult; Geriatric.
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Perform tasks related to sterile compounding, including IV infusion and aseptic technique. Perform tasks related to sterile compounding, including IV infusion and aseptic technique. Current pharmacy technician certification (CPhT) or ability to obtain certification within 6 months of hire.
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The 307-bed regional healthcare system includes Framingham Union Hospital, Leonard Morse Hospital in Natick and the MetroWest Wellness Center. Safely performs basic therapeutic and preventive nursing procedures, incorporating fundamental biological and psychological principles in giving individualized care.
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Tasks to be completed may include fermentation, protein purification, solvent extractions, tissue culture, preparation of bulk solutions, aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, routine buffer and media preparation, filtration, vial preparation and sterilization.
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Operate general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above as well as large scale bioreactor operations, critical small or large volume sterile fills, and aseptic manipulation of cell cultures.
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GMP – Aseptic and non-Aseptic Areas and Non GMP Area – Offices spaces. Test continuity of circuit to insure electrical compatibility and safety of components, using testing instruments, such as ohmmeter, battery and buzzer, and oscilloscope.
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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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Previous working experience in aseptic techniques and in flow cytometry is required. Excellent Medical Facility looking to add experienced 2nd Shift Supervisor, Genomic Medicine Bioanalytics, CT Flow Cytometry professional to their team.
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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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aseptic job Company: Tenet Massachusetts in Fayville, MA
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