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The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates.
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4-5 years of Hands-on laboratory experience is required, especially in FACS, QPCR, PCR, DNA extraction, and cell culture. Quality Control Laboratory Assistant, CTCEF. · Perform various product release assay: Viability, flow cytometry, cytotoxicity, cell growth-based assays, DNA extraction, PCR, Gel electrophoresis, QPCR, ddPCR, endotoxin, mycoplasma, ELISA.
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Prior practical experience and implementation of Quality Engineering tools and systems such as: DOE, FMEA, SPC, RCCA, APQP, PPAP, controls plans, material control, process control, systems performance, product evaluation, MSA, metrology, automated measurement, and software is preferred.
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Software application development in programming/scripting languages like Java, C#, Python, Java script and hands on experience using automation tools like qTest, Zypher or QTP/UFT, Selenium,JMeter.
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Projects will require abilities to plan systemically for technology proof-of-concept work, doing hands-on experimentation and prototyping without sacrificing quality or attention to detail, and transferring scalable solutions to MP product teams.
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Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Downstream Bioprocess – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance and drug product for clinical and commercial manufacture.
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Other development will be needed in finance, project management, regulations, and new product development in order to become a Quality Manager. The current SQF practitioner will also provide hands on experience to ensure success.
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Must understand and become proficient with Real SPC, SAP, Food Safety and Quality Plans, Water Treatment, Batching Process, Internal Sanitation, Microbiology, Environmental Monitoring Programs, and Product Testing Requirements.
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Hands-on experience with data visualization and analytic dashboard development, experience with Tableau (preferred), Domo, Power BI, Shiny, or other platforms. As required/appropriate, perform hands-on data investigation and analysis in support of program delivery, including development of conclusions and implications.
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Experience specified must include 3 years of experience with each of the following: Cognex Deep Learning to enable high-throughput fractionated blood imaging on Janus platform; Medical device development (21 CFR - Part 11); and SQL Server, Oracle, MongoDB, or NoSQL databases.
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The Quality Control Specialist will work under the direction of Senior Winemaking to focus on bottling, packaging material, and post-bottling quality controls. This is a quality control position consisting of routine analysis with a focus on overall quality at bottling.
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Must be familiar w/ the local QMS Policies and Procedures, and respective SOPs. The supervisor must practically understand how the quality data is achieved and must be proficient w/ laboratory testing methods, product standards/specifications, and demonstrate technical decision making.
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Comprehensive skills within RealSPC and the use of reporting tools to query, audit and track the following: product spec limits, product control limits, hold product, employee benchmarks, and certificates of analysis.
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Minimum of 5-7 years of experience in a Quality Control role within the pharmaceutical or biotechnology industry performing GMP analytical product testing and/or analytical development.
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As MEDIPOST embarks on a journey to halt degenerative diseases such as osteoarthritis, we are seeking a talented and experienced Product Quality Control Lead, (Senior Manager) who will contribute across all areas of our clinical program.
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quality control hands on product development jobs Company: Certis Biologicals in Missouri-city, Missouri
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