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Performs assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished, and stability products in an FDA regulated lab environment.
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Essential Functions: Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs.
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Position Overview: The Supplier Quality Engineer - Medical Device will be responsible for ensuring the quality of materials and components received from suppliers for use in the production of medical devices.
$85,000 - $125,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Provide timely testing or execution of in-process, raw materials, intermediates, API, finished goods, continuous improvement initiatives, QA training, laboratory equipment validation and stability depending on area of responsibility.
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Reject all products and materials that fail to meet quality expectations. Ensure that all packaging materials and processes comply with relevant industry regulations and standards, such as FDA regulations for food packaging or ASTM standards for materials.
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Previous technical experience should be in materials management and/or supplier quality activities associated with biotechnology manufacturing processes (large scale cell culture and purification processes.
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Analyst will perform all QC testing on incoming materials, in-process, finished products and stability studies in a time-sensitive radiopharmaceutical environment. Provides oversight related to testing incoming materials, in-process and finished products, stability studies and project support.
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Manage quality agreements with suppliers of raw materials and GMP consumables. Provides QA presence in areas of responsibility (materials management, warehouse etc.) Manage creation, revision, and obsoletion of material specifications for incoming materials.
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Performs routine analytical tests of pharmaceutical raw materials, in-process samples, blends, finished products, and stability samples using instrumentation such as HPLC, UPLC, GC, UV/VIS, FTIR, dissolution apparatus, particle size analyze, etc.
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Provides input to various layers of the organization including clinical affairs, professional marketing and consumer marketing on training and marketing materials to ensure that statements are supported by approved indications and relevant literature.
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Description: The Supervisor, Quality Assurance, schedules and coordinates daily priorities for incoming raw materials and labeling components, in-process testing, finished product sampling, in-process labeling and packaging operations, sampling and inspection activities on all work shifts.
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Conduct routine and non-routine microbiological testing of materials and cell therapy products (Gram stain, growth promotion, endotoxin, mycoplasma, sterility) Support Quality Systems such as; change control, deviation, CAPA, audits, quality metrics, etc.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Review of all US marketing materials including patient and health care provider brochures, web content, health care provider training materials and clinical evidence packages as part of the market literature creation process.
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Perform routine tests of raw materials, finished product and stability samples including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), density, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment.
$38 - $40 an hourFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Role reports to: Manager, Material QualityLocation: Summit, NJTravel %: 20What you will doThe Materials Quality Lead, is responsible for the successful development and implementation of the Supplier Quality Management (SQM) strategy and associated policies, procedures, programs, and initiatives that deliver quality, compliance, material reliability, and/or operating benefit to the supply chain.
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materials job Title: quality in Somerset, NJ
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