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B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent. Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams.
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Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance. Author, document, review quality record documentation including NC, RCI, FI and other areas of quality engineering/validation, spreadsheet validation, and equipment qualification.
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Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA. Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP’s), authoring and executing Risk Mitigation Plans as needed.
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Earned a master's or doctorate degree with a minimum of 18 or more graduate credit hours earned directly in the field of Microbiology. This course covers basic concepts of microbiology, with emphasis on medically important microorganisms and infectious diseases.
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Microbiology-Operation of Autoclave and perform control procedures such as Bio Indicator check and temperature verification. Microbiology-Operation of Autoclave and perform control procedures such as Bio Indicator check and temperature verification.
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Degree in Microbiology,Biochemistry, Chemistry or suitable corresponding experience. Degree in Microbiology,Biochemistry, Chemistry or suitable corresponding experience. Compileand maintain a high level BSP Americas Life Science Overview FAQ and sitespecific information packs / SAQs on strategic cGMP Brenntag Americas sites.
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Prepare calibration, Preventive Maintenance and operational SOP whenever required under guidance of QC Lab Manager / Director / Microbiology Manager. Coordinate with QA to complete CCR related to instruments & equipment’s in chemistry, analytical instruments, ICP-MS and Microbiology lab.
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Prior microbiology experience in a clinical or reference laboratory is highly preferred. Must possess a working knowledge of clinical microbiology processes, procedures and equipment (MALDI-TOF and VITEK2.
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