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We offer extensive facilities including PET/MRI, PET/CT, SPECT/CT, multiple medical cyclotrons, and GMP radiopharmaceutical preparation supporting cutting-edge clinical care and translational research.
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Without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. 5+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master's degree + 3 years' experience or Ph. D.
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Manage a multitude of project management tasks with varying complexity, in both GMP and non-GMP areas, including but not limited to document controls, reporting, submittal & RFI management, field quality assurances, site safety compliance, meeting minute recording during client and contractor meetings, punch list management, AHJ coordination, etc.
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The Process Engineer is responsible for developing the manufacturing process train for custom products in GMP manufacturing and bringing in new manufacturing equipment. This role works cross-functionally with Manufacturing, Process and Analytical Development, Engineering, Validation, and customers to determine process needs and requirements for transferring production processes into the GMP space.
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Preferred Qualifications: 3+ years of GMP experience in pharmaceutical, biopharmaceutical or chemistry. In this role you will be responsible for reviewing the documentation and data generated for analysis of GMP products.
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Ability to operate and maintain equipment according to safety, environmental and GMP (Good Manufacturing Practice) standards. We are looking for a Chemical Operator to join our team and play a critical role in supporting a wide range of activities for the production process; including packaging, cleaning, formulation, and material movement.
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Ensure GMP required documentation is following governmental regulations such as FDC. Experience with filtration, water pretreatment and reverse osmosis water systems; CIP/SIP systems and processes; steam, cooling water, batch mixing, sanitary piping systems; understanding of PLC functions preferred.
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Ensure all work activities are carried out according to EHS and GMP practices. Work with Reliability Engineer to plan, schedule and set up OEM Service Level AgreementsSupport Projects team with development of new assets, preventive maintenance, and spare parts.
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Assists in meat/seafood cutting to specific sizes and weights according to work order specifications and customer preferences, clean and sanitize tools ensuring all safety, Good Manufacturing Practices (GMP) and quality standards are met and to maintain the efficient flow of product through the production process.
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Ability to follow GMP and food safety requirements in a food production environment. Perform basic building maintenance and repairs including but not limited to drywall repairs, painting, and any other such type of activities that may arise from time to time.
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Knowledge of GMP, ICH, pharmaceutical compendia and FDA expectations. Work with all aspects of operations (Production, Packaging, Project Engineering, Quality Assurance, Quality Control, Maintenance.
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Support development of strategic initiatives such as GMP, Janitorial, Landscaping, MAC and multiple soft service programs on a company-wide level. Create an innovative approach to grow new business opportunities and collaborates with the Business Development Director, sales, and marketing as key contributors, maintaining positive internal relationships.
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From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
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Familiarity with FDA GMP, ISO QMS, and process validation. ASQ certification and/or Lean Six Sigma certification. Familiarity with FDA GMP, ISO QMS, and process validation. Oversee the development and maintenance of QMS, ensuring regulatory compliance.
$140,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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ASQ, QSR or familiarity with QSR/GMP regulations preferred. 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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gmp job Company: 4insite in St Louis, MO
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