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Lead and support special projects and initiatives from an IT Compliance perspective with cross functional teams including IT risk assessments, process automation, ISO, cybersecurity, data privacy, and application/IT security areas.
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Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP items to help minimize laboratory audit findings. 5+ years of experience working in a laboratory setting with a focus on Pharmaceutical and/or medical device development and testing using LC/MS, ICP-MS, and GC-MS analysis.
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Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc. Knowledge in pharmaceutical quality systems with proficiency in quality oversight of a minimum of 50% of the following: Stability, Change Control, Internal Auditing, CAPA, Exceptions, Out of Specification Investigations, Customer Complaints, Document Control, Annual Product Reviews, Equipment Qualification and Process Validation.
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Conduct routine repairs to instrumentation and electrical components in accordance with all plant work instructions and safety procedures. Associate degree or equivalent certification program from a technical school with an emphasis on instrumentation controls preferred.
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Python) and/or script writing (using Labview, Arduino, PLCs, or similar)Experience with FDA, QSR and ISO quality systems. Python) and/or script writing (using Labview, Arduino, PLCs, or similar)Experience with FDA, QSR and ISO quality systems.
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Prefer experience in working with ERCOT and TRE, or other similarly structured Independent System Operator (ISO) and Regional Entity (RE) All assets and systems are under regulation by Electric Reliability Council of Texas (ERCOT), North American Electric Reliability Corporation (NERC), Federal Energy Regulatory Commission (FERC), and Texas Reliability Entity (TRE) compliance standards.
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Ensure quality of products, customer satisfaction as well as compliance to GMP, corporate guidelines (FCPA, SOX), regulatory and international authority requirements (FDA, ISO, TÜV, GMED, etc.
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Basic understanding of industry regulatory ‘requirement and ISO standards preferredFamiliar with the setup and application of test equipment (electrical safety analyzer, digital multi-meter, patient simulator, etc.
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Together, our companies provide comprehensive solutions for everything related to customers' overhead crane and hoist, rigging, and weighing and measurement needs, including OSHA mandated inspections, preventative maintenance and repair field services, parts, engineering, ISO certified fabrication, new and replacement equipment, automated systems, system modernizations and training.
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American Equipment Holdings is an organization of leading overhead crane and hoist, industrial weighing, and below-the-hook service providers in the United States. Shannahan Crane & Hoist , a division of American Equipment Holdings, is one of the leading overhead crane solutions providers in the United States.
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Monitors and follows all production SOP's including all company, DOT, FDA, ISO, and cGMP requirements. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
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Knowledge of FDA, QSR and ISO quality systems. Knowledge of CAD systems (Solidworks, CREO, Unigraphix) Knowledge of FDA, QSR and ISO quality systems. Knowledge of electro/mechanical production processes.
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Comply with all GMP, ISO and FDA regulations for all warehouse activities. Use material handling equipment such as a floor jack, hand truck, order picker, and forklift. RF scanner or any type of scanner usage exp.
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Receipt, identification, and preparation of samples - ensure incoming samples are labeled correctly, appropriate analytical have been requested, prep and analyze samples according to ISO work instructions.
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Working knowledge of Good Laboratory/Manufacturing Practices, including aseptic technique preferred Working knowledge of FDA and ISO guidelines preferred. May be exposed to odors during media production.
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iso job in Maryland Heights, MO
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