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Developing testable requirements for GLP, GMP, and GCP laboratory equipment, automation systems, and computerized systems. This is a full-time remote role for a Laboratory Instrument Validation Specialist.
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Summary: We look forward to welcoming a Bioprocess Engineer with a solid understanding of bio-chemical engineering fundamentals and modeling expertise to support our laboratory, pilot and clinical scale process development, technology transfer to internal and external GMP production facilities for our novel cell free expression-based therapies.
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The Lab Coordinator will report to a Lab Supervisor and will be responsible for helping with the laboratory glassware cleaning, restocking, organizing, and maintenance of the GMP (Good Manufacturing Practices) analytical, formulation, and product containment laboratories.
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Responsibilities What you will be doing: The QC Laboratory Support position aids the daily activities of the GMP QC laboratories at the cell therapies manufacturing facility (CTMF) The QC Laboratory Support serves as a key resource for QC management, providing flexible cross-discipline support for Analytical equipment operation, cleaning, maintenance, and data management within the cell therapy manufacturing facility.
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Eurofins BioPharma Product Testing Australia / New Zealand provides contract GMP testing to human and animal pharmaceutical, biotechnology, medical device and complimentary medicine manufactures, as well as an extensive range of SPF and other cosmetics testing, both in-vitro and in-vivo in accordance with a range of local and international standards.
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The Quality Assurance Director will provide the Cell Manipulation Core Facility with direction and leadership in the development, implementation and auditing of Quality programs to support regulatory and accreditation compliance with applicable requirements (GMP/GTP/FACT/JC and other industry standards) as well as federal and state laws, and ensure that clinical and laboratory operations meet the highest quality standards set by the organization.
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The purification group is responsible for non-GMP protein- drug lead generation, supporting the various research units and their pre-clinical therapeutic in- vitro and in- vivo needs. Qualified candidate will play an essential role in a high-energy protein purification research laboratory within BioMedicine Design.
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A thorough working knowledge of GLP (Good Laboratory Practice), GDP (Good Documentation Practice) and GMP (Good Manufacturing Practices) is required including experience with regulatory agencies including the FDA.
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The Facility & Reliability Engineer will also support the successful operation of facility, laboratory, and business functions at multi-use GMP sites within Client, Summit West Cell Therapy Operations, through interaction with internal customers and external service providers.
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GMP Compliance: ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines.
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Lean Six Sigma Green Belt certification is a plusExperience with Agile configuration product management software - preferredExperience with Oracle and DataSweep or other electronic device history record system - preferredExperience working in a manufacturing and/or laboratory environmentGood written and verbal communication skillsSkills/Abilities:Ability to work independently as well as within a team of professionals.
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Knowledge of medical device and/or pharmaceutical industryKnowledge on renal therapies (Hemodialysis and Peritoneal Dialysis)Knowledge of GDP/GMP/GLP practices. Your RoleThe Plymouth Microbiology Laboratory Microbiologist Associate II will report to the Plymouth, MN Microbiology Laboratory Manager and be responsible for the laboratory testing including but not limited to biofilm, rapid microbiology and disinfection testing.
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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
$17 - $18.76 an hourExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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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.
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Hons Degree Qualified B.Sc. in Analytical Chemistry, Chemistry / Biochemistry, Microbiology, Molecular Biology, or related discipline, with a minimum of 5 years relevant GMP experience. The Senior Scientist Compliance role in Quality Control provides technical support for the compliance systems within the quality control laboratory.
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