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This position entails testing for GMP release and stability along with support for the validation and qualification of ELISA and Cell Based Assays. The QC Analytical Scientist will report directly to the QC Analytical Bioassay Supervisor.
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Monitor the effectiveness of quality improvements and validation activities as part of the CAPA process requirements. + Process validation; statistical process control, root cause investigation, and use of problem-solving tools.
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Advanced knowledge of FDA guidance for industry for Analytical Procedures and Methods Validation for Drugs and Biologics. Functions may include, but are not limited to: Managing QC needs for clients, developing timelines and schedules for QC needs for complex projects, communication with both internal and client facing customers, and managing change controls and revision of documents per ICH guidelines for Biopharmaceutical Drug Substance (such as product specifications, validation protocols and reports.
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Perform HPLC/UPLC testing on In-Process, DS release, DP release, DS stability, DP Stability, process validation, analytical method validation/transfer, method establishment/qualification, and various other non-routine samples.
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Managing the validation, research and updating of system data and dashboards to achieve accuracy of Legal Department reporting, including Key Performance Indicators. Other exceptional benefits include generous healthcare coverage, a 401(k) match, enhanced paid caregiver leave, and family-forming benefits for adoption, surrogacy, and fertility.
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Support qualification and validation of test methods for pharmaceutical concentration purity and impurity testing. Scientific techniques including: Protein Concentration via Shimadzu and SoloVPE Residual DNA via Real Time PCR Polymerase Chain Reaction Capillary Gel.
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Scientific techniques including: Protein Concentration via Shimadzu and SoloVPE, Residual DNA via Real Time PCR (Polymerase Chain Reaction), Capillary Gel Electrophoresis, Imaged Capillary Isoelectric Focusing (iCIEF), Dot Blot, Compendial Testing: pH and osmolalityEDUCATION: Accredited Associates Degree with 2 or more years of relevant work experience or Accredited Bachelor’s degree with GPMP laboratory experience, STEM degree preferred, technical skills, Accredited HS Diploma or GED required.
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Manage the process of NCQA certification for HEDIS measures, including data collection, submission, and validation. Bachelor's or Master's degree in Health Informatics, Statistics, Public Health, Epidemiology, or a related field.
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Assists with FCAA validations including application & classification, SSD & SEI effectivity, meeting agendas & coordination, presentation generation & review, validation work plan development. Airworthiness Certification Engineer II - Completions (St. Louis) in.
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Perform model validation against test data to inform and improve the accuracy of the simulation environment. Each day, they go above and beyond to meet our customers' overall mission requirements-from initial vehicle concept definition through design, test, validation and in-service support.
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Scientific techniques including: Protein Concentration via Shimadzu and SoloVPE, Residual DNA via Real Time PCR (Polymerase Chain Reaction), Capillary Gel Electrophoresis, Imaged Capillary Isoelectric Focusing (iCIEF), Dot Blot, Compendial Testing: pH and osmolality This position has not been approved for relocation assistance.
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Assist with clinical evaluation of prototypes by supporting ex-vivo and in-vivo Verification and Validation testing. Demonstrated knowledge of component manufacturing processes (e.g., machining, sheet metal, rapid prototyping, injection molding, etc.
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We are a protein design and engineering lab combining state-of-the-art technologies in computational protein design with experimental validation. We are looking for a computational biologist, structural biologist, biochemist or chemist, biological engineer, or Ph. D.s in related fields with an interest in designing protein structures to tackle challenging problems.
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This technician will set up and perform dynamometer, electrical, environmental, performance and agency testing to support engineering validation and design qualification of electric motors. This technician will set up and perform dynamometer, electrical, environmental, performance and agency testing to support engineering validation and design qualification of electric motors.
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Design and implement data quality checks and validation rules within the MDM solution to maintain high-quality Master Data. Experience with Google Cloud Platform, BigQuery, and Snowflake. Experience with related Data Governance concepts and solutions (Business Glossaries, Data Catalog (ideally Alation), Data Quality analysis and remediation, Data Lineage.
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validation job Company: Belcan in St Louis, MO
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