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Chemistry, Hplc, uplc, Gmp, Laboratory, Analytical chemistry, Formulation, Method validation, Development, Wet chemistry, waters hplc, empower, Quality control, R&d, Icp, ich gcp, fda compliance, documentation control.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The primary responsibility will be to interpret and report clinical cases in molecular diagnostics and assist the Division Director with assay design, feasibility studies, and clinical validation consistent with all regulatory guidelines (CAP, CLIA, FDA.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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One (1) year of proven clinical laboratory experience in diagnostic review and reporting, molecular assay design, validation, and implementation compliant with CLIA and CAP guidelines. Or, ABMGG board certified/eligible for certification in Clinical Cytogenetics and Genomics.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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5-10 years meat and/or seafood industry (as appropriate) FSQA Management experience at a federal CFIA/FDA meat and/or seafood processing plant (as appropriate) acceptable instead of a degree. Develop, lead, direct, update, reassessment, verification and periodic validation of FSQA programs including HACCP Program, Sanitation Standard Operating Procedures, Pest Control, Good Manufacturing Practices, Approved Supplier Program, Foreign Material Control, Plant Sanitation, Chemical Control, Product Quality Assurance, FSQA Customer Complaints, Food Defense and Security.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices. Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements.
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CGMP, validation and FDA industry experience desired. Primary Responsibilities: Troubleshooting of: Allen-Bradley ControlLogix, CompactLogix and SLC-500 PLCs, Rockwell Automation FactoryTalk View ME HMIs, Rockwell Automation FactoryTalk View SE SCADA Systems and Rockwell Automation Historian SE systems.
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SQF Practitioner or equivalent GFSI scheme experience, Meat and/or Seafood HACCP Certified (as appropriate) A minimum of three to five years FSQA management with additional R&D(research and development) or production-operations in a meat and/or seafood processing environment being ideal (combined experience preferred.
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Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP). Provide statistical programming and validation support for clinical study reports and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
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Experience with SCADA, MES, and database systems, or computer system validation are considered a plus. JSat Automation is hiring an Automation Validation Engineer for their Glendale Office.
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Additionally, you will provide subject matter expertise in some of the areas of toxicology that include fit-for-purpose safety biomarker development and validation, bio-fluid/tissue biomarker analysis, in silico, genetic, endocrine, and reproductive toxicology efforts to support on-going development of preclinical candidates.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Strong technical knowledge and leadership in manufacturing engineering of medical devices including process excellence methodologies such as automation, DFM, LEAN, EH&S guidelines, FDA guidelines ISO standards, Six Sigma, cGMP, supplier development and process validation.
$152,000 - $216,000 a yearExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Expertise in the SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.Experience in the development and validation of CDISC SDTM and ADaM data models by transforming raw data into standard domains and development and validation of Tables/Listings/Figures.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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This role is also responsible for submission readiness of study data packages per CDISC standards and FDA guidance, and enhancements of the statistical programming infrastructure of the Biometrics department as applicable.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Director, Research Consulting leads a team of researchers to conduct distributed network safety monitoring studies, clinical outcomes validation studies using charts, recruitment for pragmatic trials, as well as clinical program evaluation studies.
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While the Jira business processes in place will ensure SOX compliance, additional documentation may be required to satisfy FDA regulations, including the creation of documents summarizing requirements, specifications, test procedures, validation plans, system manuals, etc.
ExpandApply NowActive JobUpdated 4 days ago
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