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Solid experience in building Big Data Pipelines (Batch and NRT) on Hadoop Ecosystem including HDFS, Hive, Spark, Scala, Sqoop, Kafka, NiFi, and real time streaming technologies and host of big data open source stack.
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Author, document, review quality record documentation including NC, RCI, FI and other areas of quality engineering/validation, spreadsheet validation, and equipment qualification. Provide input and generate metrics in support of QSMR, IRB, MRB, and Product Quality review.
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As the EPC Civil Project Engineer, you are responsible as Engineer of record in the overall civil design of energy projects from conception to completion. Act as civil engineer of record for energy related projects.
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Utilize your extensive master data expertise to demonstrate a profound understanding of SAP MDG Materials, BOM, Recipes, MRP, MPS, Work Centers, Batch Management, Quality Inspection, Costing among others.
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A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is required; author position commensurate with prior academic training and working environments.
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The successful candidate will be responsible for a variety of consolidation and close functions, including intercompany reconciliation, foreign exchange analysis, journal entry preparation and review, financial statement preparation and other special projects.
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Minimum Years of Experience (Amount, Type and Variation): Required: 2 years in the Operating Room Preferred: 3-4 years in the Operating Room License, Registry or Certification: Required: Current NJ RN licensure, CNOR Certified Nurse Operating Room, BLS Basic Life Support Preferred: CRNFA Certified Registered Nurse First Assist, ACLS Advanced Cardiac Life Support Knowledge, Skills and/or Abilities: Required: Proficient with Microsoft Word, Excel, Electronic Medical Record.
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Responsibilities Works in a cleanroom or regulated area to process human and/or porcine tissue Adheres to standard operating procedures and cGMP Operates simple processing equipment including, but not limited to: heat sealers, biohazard laminar flow hoods, and mixers Monitors the quality of pre-packaged finished goods during production Records information on batch records, equipment and cleaning logs, and other documents.
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PAI or other inspection readiness plans o Submission review Review and approve GMP documents (e.g., production batch records, lab batches, API and raw materials, product specifications, analytical and micro work order reports, standard test methods, standard operating procedures, protocols for method validation, method validation reports, stability protocols and stability reports, equipment IQ, OQ. PQ qualifications and equipment calibration.
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Ensure that all documents to be submitted to regulators represent the CHC aligned strategy, are complete, accurate, compliant with global and/or local submission standards and are organized in a manner to facilitate agency review.
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Maintain strong connections with J&J sector colleagues, as well as J&J Legal, Finance, HCC, Regulatory, Clinical, Quality, and other functional groups to support, review, and execute product development projects.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Where permitted by federal or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances: Amphetamines, THC (marijuana), cocaine, opiates, phencyclidine.
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Manage key metrics for the Branchburg Quality organization, including Quality Index, Site Business Review, Quality Systems Management Review, and Post Market Surveillance Review. Own and maintain procedures for Post Market Surveillance, Quality Management System Review, and other assigned procedures.
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As a Salesforce Data Architect - in our Salesforce practice, you will be responsible for engineering, architecting, and delivering world-class solutions for our customers, producing enterprise standard implementations using the platform's full capabilities, and leading delivery teams to deliver high-quality solutions on Salesforce.com. You will be responsible for providing tailored solutions involving complex UX/UI, real-time and batch integrations, water-tight security, and custom automation.
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Responsible for batch record review activities for the site. Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others.
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batch record review jobs in Neshanic Station, NJ
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