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Extensive knowledge of applicable regulations, including GMP and food safety standards in accordance with the FDA, USDA and CFIA. HACCP certified, SQF Practitioner and PCQI certified or ability to obtain certification within 6 months of starting role.
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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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Follow all GMP, Health & Safety, Food Safety & Environmental Standards. 5 years minimum experience required as a qualified Industrial Electrician. Hands-on knowledge of disconnect switches and feeder breakers.
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Knowledge of GMP and Broad knowledge of pharmaceutical manufacturing processes is essential to understand the basic project flow interactions. We are seeking an experienced Tech Transfer Project Manager to join our team.
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Bioburden, Endotoxin, GMP, Microbiology, quality control, Laboratory, biology. The vaccine manufacturing capabilities center on large-scale microbial fermentation, purification, conjugation and cell banking.
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The ideal candidate will bring a blend of expertise in process optimization, particularly in the production of microfluidic chips and reagent kits, and hands-on experience in cleanroom and GLP/GMP environments.
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Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing Directions. Ensures manufacturing line is operating at optimum level for a GMP environment in a Safe mode while meeting production goals.
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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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Supportare i dipartimenti di Pharmaceutical Development e Drug Substance Development per gli aspetti GMP. Valutare i Quality Agreement di fornitori GMP. Verificare protocolli e report GMP.
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LIMS proficiency in GMP or GLP regulated environments. 2 years of experience collecting, cataloging and storing samples of biological material, such as urine, blood, tissue, cells, DNA, RNA, and protein.
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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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In-depth knowledge of GMP, GLP, FDA, EMA, and other regulatory standards. Ensures all clinical and commercial products comply with GMP, GLP, and other relevant regulatory standards. Oversees the development, implementation, and maintenance of quality systems, including document control, change control, CAPA, risk management, and audit programs.
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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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Live near a BioLife Plasma Services location or be willing relocate to Appleton, WI for the duration of the program. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Tuition Reimbursement Program and Paid Volunteer Time Off.
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General understanding of GMP and/or GCP regulations as they relate to the development, distribution of drugs, medical devices, or supplements in North American markets. General understanding of GMP and/or GCP regulations as they relate to the development, distribution of drugs, medical devices, or supplements in North American markets.
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gmp job in Morrisville, NC
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