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Bachelor of Science in biology, chemistry, biochemistry, microbiology or similar relevant education. Related experience with Biopharma cGMP manufacturing processes. 2+ years of experience in the field of plasmid DNA, mRNA, proteins manufacturing services or cell and gene therapy at a commercial CDMO.
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Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology. Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records.
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Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus. Ensures compliance with cGMP and safety requirements. Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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Performs basic Analytical and microbiological assays and lab procedures using appropriate laboratory techniques and in compliance with GLP, cGMP, and/or PTC and SOPs. Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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The Field Service Engineer (FSE) - Microbiology Specialist's primary responsibility will be to provide routine to complex field service and support for our Sievers brand endotoxin and bioburden analytical instruments.
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Prefer but not required, some working knowledge of Hazard Analysis of Critical Control Points (HACCP), current Good Manufacturing Practices (cGMP), Food Safety Modernization Act (FSMA), Food and Drug Administration (FDA) Model Food Code, Code of Federal Regulations (CFR), and general microbiology.
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The successful candidate will have a high school diploma with a minimum of 5 years process operations experience, A.A.S. or B.S. degree is preferred. Operates control systems and processes in Biotechnology Pilot Plants as assigned.
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This position will serve as the primary SQF Practitioner for the Seattle/Renton Distribution location with guidance and support from the Director of QA for OB Distribution Group. The QA Manager for Seattle-Renton Distribution is responsible for managing the programs, policies, and procedures at the Seattle-Renton facility located in Renton, WA., ensuring compliance with HACCP-Food Safety as they relate to state and federal regulations including the National Shellfish Sanitation Program (NSSP) and FDA, customer requirements, and 3 rd.
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Understanding of cGMP/GLP and GDPs practices and EHS requirements of pharmaceutical lab and production environment. Working understanding of microbiology principles related to pharmaceutical water quality testing.
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BS in Microbiology, Biology, Biochemistry or related field and a minimum of 15+ years of relevant experience within the pharmaceutical industry and a minimum of 8+ years of hands-on, industry experience managing a cGMP QC laboratory.
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Establish process and documentation for EM monitoring program to support cGMP manufacturing (MFG) operations. Quality Control Senior Associate / Supervisor: Microbiology and Environmental Monitoring.
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Master's degree in Biochemistry, Biotechnology, Microbiology, or related field; advanced degree (e.g., Master's required or PhD preferred). Strong knowledge of regulatory requirements for biologics, including cGMP, ICH guidelines, and relevant pharmacopeial standards.
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Performs product preparations in compliance with FDA, cGMP, AABB standards and blood bank department procedures, if applicable. The Medical Lab Scientist provides comprehensive laboratory testing for patients.
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Working in fermentation technology and downstream in small scale/pilot laboratories, in cGMP production environment and experience working in regulated environments. Good scientific knowledge in industrial microbiology and fermentation technology.
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Bachelor's Degree in Biology, Biochemistry, Microbiology, or life sciences related field, or equivalent education. The FSE - Microbiology Specialist position will require frequent overnight travel in support of our endotoxin and bioburden customers as our product line and customer base matures.
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