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Execute cGMP testing and report findings in the Quality Control Microbiology Lab. 2-5 years of experience in cGMP microbiology with strong expertise in testing, analysis, and documentation.
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The ideal candidate will have direct experience working in a commercial cGMP microbiology laboratory, a keen attention to detail, and is highly organized in their work. Support investigations into microbiology deviations, CAPA, and OOS investigations.
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Communicates Microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to R&D Microbiology Manager, Assistant Director of Microbiology, Director of Microbiology, or designee.
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Performs microbiology department related raw material, in-process, and finished product testing according to USP methods and established procedures that follow cGMP guidelines and demonstrate outstanding aseptic techniques.
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Strong technical skills and experience in commercial biopharmaceutical Quality/Manufacturing in the areas of microbiology, environmental monitoring, microbiological testing, cell culture and/or purification, engineering or validation.
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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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Familiarity with general chemistry, microbiology, or clean room operations. Prior experience with cGMP operations or aseptic technique. Familiarity with general chemistry, microbiology, or clean room operations.
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A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
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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. Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus.
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The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs. Experience: At least two years in a cGMP laboratory setting.
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As a Microbiologist you will apply cGLP, cGMP, ANSI, AAMI, ISO, EUMDR, FDA and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopaedic implants and surgical instruments for Stryker’s Leesburg, VA facility.
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Bachelor’s degree in biology, health science, or microbiology. Our Client, a leading contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies, is seeking a Microbiologist II to join their growing team.
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You'll be responsible for providing Quality Systems oversight and support for the development and operations of a commercial scale state-of-the-art cGMP cell therapy manufacturing and laboratory facilities.
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Oversee all aspects of Quality Management System (QMS) processes including Change Control, Deviations, CAPAs, and Task Writes, ensuring compliance with internal SOPs, FDA, and cGMP regulations.
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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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