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This individual will independently run HPLC, GC, chromatography, and various other analytical chemistry techniques to support clients while utilizing cGMP processes and procedures. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
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One year of experience auditing laboratory documentation in a regulated environment (i.e. FDA, GLP, etc. 1 year of experience with FDA regulations (cGMP, GDPs, adherence to USP, BP, etc.
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Familiarity with cGMP, Good Laboratory Practices (GLP), and project management principles. Bachelor's degree in Pharmaceutical Science, Chemical Engineering, Food Science, Chemistry, or a related scientific discipline.
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BS in Microbiology, Biology, Biochemistry or related field and a minimum of 15+ years of relevant experience within the pharmaceutical industry and a minimum of 8+ years of hands-on, industry experience managing a cGMP QC laboratory.
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This position will develop and review protocols for new and existing cGMP systems, including manufacturing equipment, laboratory instrumentation, and processes, across our network of manufacturing facilities.
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Author, execute, review, and summarize commissioning and qualification protocols for GMP systems including manufacturing equipment, laboratory instruments, utilities, spreadsheets, computer systems and processes.
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1-5 years’ experience performing commissioning, qualification and validation activities in an cGMP manufacturing and/or laboratory environments. Maintaining an up-to-date knowledge of validation requirements, practices, and procedures including an understanding on GxP, GAMP5, cGMP, CFRs (Part 11, 210, and 211), FDA/EU regulatory requirements and associated guidance documents.
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The Senior Validation Engineer is responsible for supporting the validation program for Cardinal Health’s Nuclear and Precision Health Solutions (NPHS) organization. Senior Validation Engineer, Quality Engineering.
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Mentor and guide cross-functional team(s) on all aspects of Technology Transfer of gene therapy processes from Process Development into the MSAT laboratory and then into cGMP production.
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Bachelor's degree in Engineering or a Physical Science preferred. Experience in Biotech, Pharmaceutical or Medical Device operations including protocol development and field execution, preferred. Experience with GMP manufacture of radio pharmaceuticals, preferred.
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Advanced knowledge of pharmaceutical, manufacturing and laboratory systems. The Equipment Validation Engineer supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers.
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Demonstrated work experience in compliance with cGMP and FDA requirements, including Good Documentation Practices (GDP). Ensure calibration testing on laboratory equipment follows established protocols.
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Sample using Z1.4 testing tables and cGMP practices. Maintain all laboratory equipment and ensure timely calibration where required. Follow all cGMP and safety requirements and procedures.
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The LQA Analyst II will focus on Analytical Data Review and must be familiar with applicable cGMP regulations and systems and can make decisions based those requirements. Provide quality support to laboratory material receipt, controlled substance program, pest control, calibration, stability, and other laboratory needs.
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The Medical Lab Scientist provides comprehensive laboratory testing for patients. Performs product preparations in compliance with FDA, cGMP, AABB standards and blood bank department procedures, if applicable.
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