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Grand River Aseptic Manufacturing, Inc Microbiologist I in Grand Rapids, Michigan

DescriptionuJOB SUMMARY/uSupports quality systems as they relate to the manufacturing and testing of cGMP drug products. These duties will include, but not limited to, providing general laboratory support for raw material, in-process, stability, and finished product testing.bruESSENTIAL DUTIES RESPONSIBILITIES/uulliPerforms sampling of water pure steam to support manufacturing activities./liliPerforms Environmental Monitoring of aseptic filling rooms and supporting areas./liliPerforms Compressed Air and Gas Sampling and Testing./liliPerform sampling to qualify Manufacturing operators for aseptic gowning./liliPerforms bioburden testing of water an in-process samples to detect microorganisms and to obtain information on types and levels of microbial contamination. /liliPerforms Total Organic Carbon, Endotoxin, Nitrate, and Conductivity testing on water./liliMaintains laboratory equipment - cleaning and calibration./liliPerforms daily, weekly, and monthly lab maintenance and stocks supplies./liliReceives incoming samples for testing./liliPerforms incoming material testing and inventory./liliPerforms Swab sampling and testing of manufacturing equipment./liliPrepares Reagents and Standards used for testing./liliPerforms Bioburden and Endotoxin testing on client specific raw materials, in-process samples, and finished products./liliReads plates generated from environmental monitoring and laboratory testing./liliPerforms testing on biological indicators to support Validation studies./liliPrepares isolates for microbial identification./liliData entry of results generated by Laboratory./liliComplies with applicable GMPs./liliMaintains good practices with regards to processes and/or internal conditions leading to an aseptic environment./liliMaintains laboratory logbooks and other forms to document proper GLP testing./liliPerforms all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice./liliOpen to a flexible and fluid work environment./liliSupports Agency, customer and vendor audits as needed./liliResponsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices./liliPerforms all other tasks, projects, and duties as assigned./li/ulbrRequirementsuDESIRED SKILLS ABILITIES/uulliProficiency in aseptic technique./liliAbility to interpret and relate Quality standards for implementation and review./liliProficiency in both written and verbal communication and presentations./liliEnergetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment./liliResults oriented and efficient./liliCreative and open-minded who fosters an environment in which sharing of ideas is encouraged./liliAbility to work closely with a diverse customer base (internally and externally)./liliAbility to work well in a cross-functional team environment./liliMust have proficient computer skills in Microsoft Word, Excel and Outlook./li/ulQualified candidates have completed a Bachelor's Degree in Microbiology or a related field and 2-4 years' related work experience. Aseptic filling experience preferred. Knowledge of QA principles a