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Quality Assurance/QA Specialist Bio-Analytical GLP. Title: Quality Assurance Specialist – GLP Bio Analytical. Reports to : Director BIO GLP Quality Assurance. Support and train staff on GLP regulations and SOPs as needed.
$62,400 - $90,000 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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Conduct bioanalytical sample analysis for non-GLP and clinical studies. Understanding GLP and GCP regulations as relates to bioanalysis. Prior experience and good understanding of cell-based assay development, cell culture techniques and flow cytometry methods are desired.
$113,000 - $160,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Have working knowledge of bioanalytical assay development and qualification/validation requirements, ICH GLP, and GCP guidelines. Have working knowledge of bioanalytical assay development and qualification/validation requirements, ICH GLP, and GCP guidelines.
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Partner with lead bioanalytical scientists and study directors to manage external contract research organizations, including managing contract execution, creating statement of work, assay development or transfer, and overseeing sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases.
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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
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Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations application of CGMP/GDPs. Perform surface sample testing using plate and/or swab method. Operate equipment such as SAS Air Sampler and Non- Viable Particle Counter for the purpose of collecting air/particulate samples.
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Perform routine environmental monitoring for cleanrooms, compressed gas systems and water systems. Ensure Environmental Monitoring area is always maintained in a GMP state while following all EHS and 6S guidelines.
$56,000 - $77,000 a yearExpandUpdated Today - UpvoteDownvoteShare Job
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Following Standard Operating Procedures (SOPs), Good Laboratory Practice(GLP) and Good Documentation Practice (GDP) This R&D/ Manufacturing Technician must also be comfortable safely operating some of the larger Manufacturing equipment.
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Knowledge of Current Good Manufacturing Practice (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), GAMP5, 21 CFR part 11 and ICH. Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform.
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Working knowledge of GMP/GCP/GLP/GDP regulationsExcellent oral and written communication skills; along with strong demonstrated stakeholder management skillsExcellent project management and organizational skills; ability to plan and execute multiple on-going projects with easeJOB COMPLEXITY:Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Expertly support the Biosample Managers to deliver the sample strategy for clinical trials within the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP. Understanding of ICH GCP and GLP guidelines.
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Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Knowledge of GMP, 5s, GLP, HACCP and Quality & Food Safety Systems. Maintain proper calibration/verification of laboratory equipment and document in the Internal Control Plan. Take appropriate action to correct equipment deviations or notify QA Supervisor of any problems.
Full-timeExpandUpdated 10 days ago - UpvoteDownvoteShare Job
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Implement and utilize multiple technology platforms including MSD, Luminex, Simoa and colorimetric / luminescent plate readers. The Senior Bioanalysis Scientist I is responsible for assay development, validation, and sample testing to support non-clinical and clinical studies for a fast-growing Exelixis pipeline of novel biotherapeutics.
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We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Support Conduct specific chemical and physical analysis on medical devices through all stages of the manufacturing process from incoming raw materials to finished goods.
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