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Ensures that team members are in full compliance with written protocols, SOPs, HMH policy and GCP, IRB policies, FDA regulations and Joint Commission rules. Working knowledge of FDA and DHHS regulations, Good Clinical Practice Guidelines, CITI and Safety/IND reporting.
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BS in business administration or project management with 6 years working in a global manufacturing company in FDA regulated environment. The Transportation Project Manager will be responsible for enabling Integrated Transportation Management Planning and Carrier Collaboration Platform for managing Domestic and International Freight-in/out across SAP and JDE North America systems.
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Demonstrated expertise in the function, clinical issues, and performance requirements of orthopaedic implants, instruments, and procedural workflow within an FDA regulated industry. Experience with 3D printing and coded manufacturing.
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Looking for someone with 3 or more years of experience that has worked in a Quality enivornment FDA CFR or ISO. The temp will be involved with "Supplier Management System" background Med device or Pharma.
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Work with Epic and Ops team to design more efficient processes for powder blending, ensuring compliance with FDA, cGMP, and OSHA requirements. -Knowledge of food safety regulations (e.g., FDA, HACCP.
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The QA Microbiology Lead will be responsible for Microbiological Testing, as per USP, performing all microbiological analysis on raw and finished products, using expert knowledge of FDA and BAM procedures, as well as environmental quality of manufacturing area.
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POSITION SUMMARY:To independently perform and report laboratory findings in accordance with policies and procedures of The Department of Pathology and Laboratory Medicine, FDA, CAP, AABB, OSHA, CLIA, and TJC regulations to facilitate quality patient care.
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Knowledge of rules and regulations (FDA, CTFA, PCPC) for formulation. Master's degree in Cosmetic Science or related field, preferred. Knowledge of rules and regulations (FDA, CTFA, PCPC) for formulation.
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Perform calibration of pneumatic and electronic control instruments consistent with FDA and NIST standards. Perform calibration of pneumatic and electronic control instruments consistent with FDA and NIST standards.
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The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA.
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To independently perform and report laboratory findings in accordance with policies and procedures of The Department of Pathology and Laboratory Medicine, FDA, CAP, AABB, OSHA, CLIA, and TJC regulations to facilitate quality patient care.
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While prior knowledge is always a plus, we are happy to provide thorough training on OSHA (Occupational Safety and Health Administration), FDA (Food and Drug Administration), and FSMA (Food Safety Modernization Act) regulations.
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Experience in the drug/device combination product regulatory framework (FDA, MDR, etc) Our advanced drug delivery solutions (ADDS) include well known products such as the BD PhysioJect™ autoinjector, the BD Vystra™ multidose pen, the Libertas™ Wearable Injector, and the Evolve™ On-Body Injector.
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Maintain proper tagging of raw materials and product liquids to confirm to FDA and GMP regulations. Must have directly related experience in an FDA regulated manufacturing facility. The company is seeking an individual who has directly related experience working in an FDA regulated manufacturing facility.
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Document and complete service administration activities in a timely manner to follow ISO, FDA, and Leica policies. The Field Service Engineer II for Leica Biosystems is responsible for supporting the needs of our customers, which directly impacts patient health and overall well-being.
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