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Responsible for leading and managing the analytical development and support of the analytical quality control strategies during late stage and post approval (commercialization) phases. This role requires matrix leadership of scientists supporting commercialized and late-stage biopharmaceutical products with a focus on establishing the analytical CMC strategy, enabling regulatory filings, providing technical partnership for quality control laboratories around the world, managing the life cycle of specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Strong technical background in assay development, pharmaceutical analysis, bioassay, impurity testing, microbiology support, quality control, and stability management. Ph. D. or M.S in Biology, Chemistry, Micrology or related biotechnology discipline with a minimum of 15 years of Quality Control experience in biopharmaceutical or biotech industry.
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Kelly is hiring for a Quality Analyst - Bioassay position with one of our clients in Union City, GA. Be a fully trained and dependable analyst in Bioassay. These tests include flow cytometry, ELISA (Bead Identity), endotoxin, complete blood count (CBC), viability, gram stain, etc.
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This individual will join the Quality Control Bioassay team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. The role is responsible for conducting routine/non-routine testing and analysis of GMP product using methods such as ELISAs, qPCR, and cell-based assays at both Washington state facilities.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Analytical Scientist role in Analytical Sciences/Quality Control Laboratories will be responsible for provision of analytical methods, data and information using advanced analytical mass spectrometry techniques in supporting individual site and network projects.
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The opportunityThe Bioassays and Potency Analysis group strives to deliver creative medicines to patients through performance of bioassay, potency and impurities testing activities within a GxP-compliant QC laboratory to support pre-clinical studies and clinical development for biological products manufactured in a GMP production facility.
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We are currently looking to fill a Quality Control (QC) Analyst on our Bioassay team with a Mon - Fri, 12 PM - 8:30 PM schedule. To be considered for the Quality Control Analyst on our Bioassay team you must be willing and able to work Mon - Fri, 12 PM - 8:30 PM. You must have the following; BS/BA in Life Sciences or related field; will substitute relevant experience for education.
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We are seeking a contract role in Quality Control Sample Management Associate II based at their Norwood, MA site. General knowledge of industry standards and guidelines for quality control laboratory operation.
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The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs. Participate in authoring quality systems records such as deviations, change controls, CAPAs.
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Skills: Quality control, Cell Biology, GMP (Good Manufacturing Practice) In this role, you will support QC Bioassay Labs with review of test records and documents. In this role, you will support QC Bioassay Labs with review of test records and documents.
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Quality Control, Bioassay Associate 1. Work with the quality control management team to continuously improve the quality, compliance, and efficiency of QC operations.
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The ideal candidate holds a M.SC. or Ph. D. degree in life sciences and has preferable experience from the pharmaceutical industry preferable from Quality Control or an Analytical Development department.
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A minimum of 10 years experience in dosimetry, quality control and radiation detection instrumentation. As an Advisor the individual would be periodically called upon to provide technical advice , for Internal and External Dosimetry and provide the following deliverables:Revise the quality assurance plan, the Internal dosimetry quality assurance and quality control documents to align them with current dosimetry functions.
Part-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Associate II, Quality Control - Sample Management. This position will support first shift QC Sample Management operations, Wednesday through Saturday. Associate II, Quality Control - Sample Management.
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In 2012, I returned to Lonza Singapore as a full-time Quality Control Analyst, performing day-to-day testing of cell therapy products and environmental monitoring of cleanrooms. A decade on, Grace is now a section lead in the Quality Control department, and she has enjoyed every moment of her Lonza journey so far.
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