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Verify inspections and testing of raw materials to ensure vendor compliance. Extensive knowledge of Dietary Supplements CGMP activities and Quality Systems. Review cGMP documents for compliance with standards and regulations.
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The Senior Specialist of Quality Assurance (QA) Lot Disposition is a full-time position located at the BMS Cell Therapy Manufacturing Plant (Jump) in Bothell, WA. The primary focus for this role is to ensure final drug products and incoming raw materials are released to market following all internal procedures and cGMP requirements.
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This person is responsible for the governance of the GMP facility environmental monitoring and contamination control program including the qualification of the GMP facility and maintaining the qualified status, aseptic process simulation, disinfection procedures/practices, disinfectants qualification, cleaning validation, and oversight of microbiological testing of raw materials, intermediates, drug substance, and finished goods.
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Represent the MSAT function in cross-functional teams as a materials science technical subject matter expert for single-use systems, cell culture media, and/or small/large molecule raw materials.
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Working knowledge of raw materials testing and release. Hplc, sap, Karl Fisher, FRIT, uplc, GC, gas chromatography, raw material, Chemistry, Quality control, Analytical chemistry, Gmp.
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The Chemist II, under general supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability, and finished products, and testing to support process validation.
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Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS Has demonstrated competence in conducting chemical analyses Good knowledge of wet chemistry techniques In-depth working knowledge of laboratory software and chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax) Competency in Microsoft Office Suite P#1 Email resumes to Jacqueline.
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The Materials Technician receives, ships, stores and distributes raw materials, intermediate and marketed products in compliance with cGMP and company SOPs. Ship materials as requested using any of the major carriers: FedEx, UPS, DHL or US Mail.
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Perform Document review of anticipatory and as appropriate non-sterile to sterile compounding batch records: Verify that raw materials meet specification limits. Adheres to cGMP, cleanroom-controlled environments requirements and SOPs. Other tasks may be assigned as deemed necessary by the Laboratory Supervisor/SMEs. Experience/Training/Education/Etc. Bachelors degree in a science such as Biology, Microbiology, or Chemistry with a minimum of 1 year of experience in quality or manufacturing department of a Pharmaceutical, Medical Device or any regulated industry.
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The Processing Technician is responsible for the quality and quantity of actual batch of raw materials to produce a finished bulk product by product formulation and specific manufacturing procedures.
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QC Chemist Perform release, stability and special request testing of finished products and raw materials following Standard Operating Procedures (SOPs), in-house test methods, and/or compendial methods.
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Type Direct Hire QC Chemist Perform release, stability and special request testing of finished products and raw materials following Standard Operating Procedures (SOPs), in-house test methods, and/or compendial methods.
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The Microbiologist is responsible for and has experience in performing microbial analysis for the QC Microbiology laboratory which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation), and environmental samples, as assigned, and documenting results in accordance with SOPs.
$35Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Performs a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures.
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As Microbiology QC Analyst, you will work in the QC Microbiology Lab, being responsible for conducting biological or chemical and physical analyses on raw materials, in-process samples, final product samples and other samples collected from manufacturing areas.
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