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Thorough knowledge of cGMP, ICH guidelines, current USP policy and methodology, FDA guidelines and inspection requirements, and industry guidance in the areas of pharmaceutical microbiology.
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Experience in general computer operation, Non-viable particulate counter, Metasys, Viable air sampler, aseptic gowning, cGMP, and regulatory requirements. Communicates quality-related observations, issues, problems, discrepancies, and any other violations of company policies or procedures to EM Supervisor, EM Assistant Manager, EM Program Manager, Director of Microbiology, or designee.
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Keywords : Microbiology, Microbiologist, QC, Endotoxin, Environmental Monitoring, cGMP, GMP, pharmaceutical manufacturer, manufacturing, Aseptic Manufacturing, Microbiological Laboratory Operations, regulatory, Utility Monitoring, environmental sampling, EM Plates, TOC analysis, Conductivity, Biological Indicators, KTA LAL, Bioburden, Growth Promotion, Micro-IDs, Gas Testing, LIMS, SAP, Trackwise, Investigations.
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Experience with regulatory requirements for biopharmaceutical manufacturing, including cGMP and FDA guidelines. Support regulatory compliance by ensuring adherence to relevant quality standards, including cGMP, ISO, and FDA guidelines.
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Education and/or Experience: Bachelor’s degree in related field preferred (Microbiology, Biochemistry, Chemistry, Molecular Biology, etc.) Execute Standard Operating Procedures to meet current cGMP / ISO / MIOSHA / MDEQ or other regulatory requirements.
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7+ years experience in a GMP environment with knowledge of cGMP regulations and a background in microbiology. Requirements Bachelor's degree in Biology, Microbiology, or other laboratory-based life science; or equivalent combination of education and experience.
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Synergy Bioscience is a CRO providing pharmaceutical product development support, analytical chemistry, and microbiology testing services to different industry sectors. Knowledge of FDA regulations and cGMP work requirements as they relate to lab operations.
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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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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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Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities. Bachelor's degree in related science field, or equivalent work experience (Microbiology, Chemistry, Biology, Physics) preferred.
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The microbiologist will also maintain to microbiology laboratory, including cleanliness and maintain supplies to perform microbiological testing. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.
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The successful candidate will have a high school diploma with a minimum of 1 year process operations experience, A.A.S. or B.S. degree is preferred. Our client, a leading pharmaceutical company, is hiring a Bio Process Associate on a contract basis.
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Vor Bio is seeking an experienced Quality Control Senior Analyst to be a part of the team responsible for the day-to-day operations assigned to the QC Microbiology group, including sampling of a cGMP manufacturing facility, testing samples in the QC Microbiology laboratory for batch release of advanced therapeutics including cellular and gene therapy products.
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The main responsibility for the Synthesis and Production Microbiology Supervisor is to lead and oversee all production activities associated with oligo synthesis and production microbiology in a multi-product cGMP facility.
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Experience: 2-4 years in the Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes.
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