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In addition, the individual will execute and participate in the execution activities for scale-up and system operations supporting the manufacture of preclinical, clinical, and commercial biologics drug substances, including operation of cell culture bioreactors and harvest equipment, GMP documentation, and ensuring compliance to relevant regulations.
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The trainer will adhere to all GMP guidelines to and from the production floor; including but not limited to utilizing both handwashing and sanitizing stations, wearing of lab coat smock, no candy, food, gum, tobacco or lozenges in both the locker room and on the production floor.
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Perform routine ICP-MS and ICP-OES analysis for trace metals in a GMP analytical laboratory. Perform routine ICP-MS and ICP-OES analysis for trace metals in a GMP analytical laboratory. Experience with ICP-MS and/or ICP-OES analysis.
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Coordinate with Lean Manager to develop and execute Pull Plans for design, estimate and GMP schedules. Essential Duties & Key Responsibilities:Accountable for Preconstruction deliverables for complex mega projects or portfolio of large projects, including but not limited to Guaranteed Maximum Price (GMP) and Lump Sum bids.
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Must follow GMP Policy - wear company issued shirt, hat, safety glasses, earplugs and hairnet in production areas. The QA Technician reports to QA Manager. Must be able to work 12 hour shift (days or nights) on a rotating schedule.
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Abides by Niagara’s Good Manufacturing Practices (GMP) and Food Safety Standards at all times. Production Operator (Nights)This position is responsible for daily operations of the production floor; ensuring the shift meets established safety, quality, and production goals in compliance with all applicable legal and food safety requirements.
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Ensure laboratory area is always maintained in a GMP state while following all EHS and 5S guidelines. Job Summary The Microbiology Lab Analyst will be based in Austin, Tx. The Microbiology Lab Analyst will support laboratory validations and routine microbiological testing such as but not limited to bioburden, endotoxin, media qualification, compressed air and environmental monitoring.
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These duties include loading, unloading, order fulfillment, verifying/documenting receipts and shipments, inspecting orders, stocking, sit-down forklift operation, operating box trucks, inventory control and reconciliation, and facility GMP.
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Experience in a GMP and ISO regulated facility preferred. Troubleshoots equipment breakdowns and performs mechanical, pneumatic, and electrical maintenance whenever required to ensure uninterrupted customer supply.
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GMP Document Control Specialist. GMP Document Control Specialist. Some labeling experience strongly preferredEducation/Experience:Bachelor's degree or equivalentMinimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environmentWhat's In It For You.
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Experience launching new products in a GMP and regulated environment (Pharmaceutical, Medical Device and Diagnostics, or Consumer Products) is required. Experience with Six Sigma/Process Excellence Tools, Training and/or Certification is preferred.
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Be a champion for safety, quality and GMP standard as needed. Ensure that all production processes and products adhere to GMP standards and customer specifications, and are in compliance with the company’s HACCP Plan.
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The Automation Engineer will be responsible for designing, testing, and troubleshooting automated PLC processes/GMP utilities equipment and systems in partnership with our Client’s Life Sciences and Pharmaceutical manufacturing facility.
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Keep extrusion equipment, work area and floors neat and orderly and comply with GMP requirements. Keep extrusion equipment, work area and floors neat and orderly and comply with GMP requirements.
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Comply with all company Quality, HACCP, GMP and Food Safety Standards. Must be able to stand for the duration of a 12-hour shift with applicable breaks. Support and perform tasks related to startup, changeover, cleaning, and shutdown of work areas and equipment.
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