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Receiving, aliquoting, distributing, handling and documentation of GMP samples in support of multi-product and multi-site testing laboratories. Knowledge of GMP concepts. We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.
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Experience working in a SOX/GMP Validated environment a strong plus. SOX/GMP Validated environment: 3 years (Required) Ensure functional work activities are conducted in compliance with technology and GMP requirements, related policies and procedures, and corporate objectives.
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Prior professional experience in a GMP regulated environment or semi-conductor industry is highly desirable. Prior professional experience in a GMP regulated environment or semi-conductor industry is highly desirable.
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Knowledge of CMC drug development process/requirements within pharmaceutical and/or biopharmaceutical industries and GMP requirements as it relates to regulatory requirements for assessing changes throughout development.
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10+ years of experience in the biotech/pharmaceutical industry, with 5+ years of experience in a GMP Quality Assurance function and experience managing contract vendors. Monitor industry trends and current regulatory expectations to ensure evolution of the GMP Quality Management System and compliance strategy.
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The QC Analyst will support the gene therapy program pipeline including but not limited to routine GMP microbiological testing of AAV vector such as bioburden and endotoxin. This analyst also will support microbiological water sample testing in support of the GMP manufacturing facility.
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Assist in the review/resolution of accounts payable/receivable invoice discrepancies, to ensure timely resolution Evaluate/propose enhancement to current materials handling/storage/flow process to ensure timely availability to the production floor in a GMP compliant manner.
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A master's degree in biology, Chemistry, Engineering, or related Technical Physical Science with 2+ years of experience in GMP Pharmaceutical Manufacturing Environment required. A bachelor's degree in biology, Chemistry, Engineering, or related Technical Physical Science with 3+ years of experience in GMP Pharmaceutical Manufacturing Environment required.
$78,000 - $95,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Knowledge of design requirements related to food safety, including SQF, FDA, GMP. Knowledge and experience with intermediate-level statistical analysis and associated software (e.g. JMP, Excel, Minitab); Six Sigma Green or Black Belt certification is a plus.
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Performs analyses of Clinical Chemistry, Co-Oximeter, Coagulation and/or Microbiology controls and reagents using various automated and manual techniques in accordance with established Quality and GMP requirements.
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Knowledge of GMP working environments Key Skills, Abilities, and Competencies Have basic knowledge of mammalian cell culture Independently design and execute cell culture experiments related to characterization of cell culture parameters Apply engineering principles in scaling up from bench to pilot plant or GMP manufacturing scale.
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Arrange and execute Temperature Sensitive GMP Controlled Ambient and Cold-Chain (refrigerated, ultra-cold, cryogenic etc) shipments with coordination internally and with shipping provider/carrier, shipping documentation compliant to GMP, Export Import, USDA, FDA, FWS/CITES etc regulations.
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Maintains documentation of all work performed in accordance with GMP requirements. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials.
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CuriRx focuses on formulation and lyophilization development of biologics, small molecule, analytical development, and GMP manufacturing of biologics. CuriRx goal is to transition to a full service GMP biomanufacturing and we are looking for the right person to help us achieve this vision.
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