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Preferred: 3+ years of GLP/GMP environment in laboratory operations or QA, or combination of bothAdditional InformationPosition is full-time, Monday - Friday 8:00am - 5:00pm. Preferred Associate’s Degree and/or certifications in laboratory/quality/regulatoryRequired: Understanding of FDA requirements and Quality SystemsPreferred: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)Preferred: 1 – 2 Years in a laboratory environment.
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Participates in managing the budgets and estimates at various stages of each project and helps to maintain Master Budget Template, GMP Estimate Roll-Up, and cost guidance models for various key project inputs.
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Experience working with SOPs, GDP, GMP, CLIA, and the FDA. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. That’s how we tackle rare disease. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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The micro-cleaner is a critical role in the company which ensures the proper cleaning of the cleanroom, controlled environment and GMP laboratory environments. Responsible for participating in continuous training: cGMP training, technical skills, safety, performance improvement.
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0-3 years of experience in a GMP-regulated environment within the biotech, gene therapy or related industry. The GMP Facilities/Plant Engineer will be the responsible engineer for the facility's GMP utilities and cleanrooms.
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General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
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Hplc, quality control, gmp, uplc. Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP environment. hplc, quality control, gmp, uplc. Experience with relevant analytical lab equipment (HPLC, PA800 Plus, UPLC) and computers.
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5+ years of experience validating manufacturing equipment in an industrial/GMP environment. If so, then join our growing team as a Validation Engineer and play a vital role in safeguarding the integrity of our pharmaceutical products.
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Advises internal teams on the application of drug and device laws and regulations, as well as Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) as well as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) as they relate to clinical research.
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The GMP Tech will be responsible for keeping assigned areas within GMP in clean and orderly condition. Perform sanitization duties to maintain a GMP controlled environment. Perform repetitive tasks in a GMP environment.
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Strong knowledge of GxP Requirements, GLP and GMP regulations, 21 CFR part 11 requirements. We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc.
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The Manufacturing Sr Engineer I designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification.
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Supporting tech transfer of new products and processes to ensure smooth transition from R&D to process development to GMP manufacturing through evaluation of key product parameters. Supporting tech transfer of new products and processes to ensure smooth transition from R&D to process development to GMP manufacturing through evaluation of key product parameters.
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Strong understanding of regulatory requirements, including FDA and GMP. This position is eligible for hybrid or possibly fully remote work. The Technical Writer, reporting to the Director of Facilities will be responsible for writing and developing Standard Operating Procedures (SOPs) and other process documents for the Facilities and Engineering (FandE) department.
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Position Description: Quality Control Inspector for quality-minded individual with a growing, high-end GMP printing and packaging company with the ability for potential growth within the organization.
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gmp job in Morrisville, NC
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