Microbiologist I

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    "description": "<p>The Microbiologist I is responsible for all duties related to performing environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. &nbsp;The Microbiologist I is also responsible for performing all the microbiological testing related to raw materials, utilities, and in-process product testing. &nbsp;Other responsibilities include data entry, data review, ensuring calibration of equipment, maintaining and ordering inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order.</p>\n\n<p><strong>**Please note that the shift for this position will be from 7PM-5AM.**</strong></p>\n\n<p>Level 1&nbsp;<br />\n-&nbsp;&nbsp; &nbsp;Less than 12 months experience or no experience<br />\n-&nbsp;&nbsp; &nbsp;Environmental Monitoring Completion<br />\n-&nbsp;&nbsp; &nbsp;Utilities completion<br />\n-&nbsp;&nbsp; &nbsp;Microbial Identification (subculture, Gram-stain, ID entry, VITEK MS assist) and enumeration<br />\n-&nbsp;&nbsp; &nbsp;Raw Material Testing including APIs</p>\n\n<p>Responsibilities:</p>\n\n<ul>\n\t<li>Responsible for performing all microbiological testing of raw materials, utilities, and in-process, and final products/stability (as applicable) for commercial and method development.</li>\n\t<li>Responsible for performing daily, weekly, semi-weekly, and monthly environmental monitoring of the manufacturing environment and other areas.</li>\n\t<li>Responsible for performing enumeration, organism identification including culturing, isolating, entry, and maintaining of organisms.</li>\n\t<li>Document and review of raw and final data to ensure complete and proper documentation according to procedures and applicable cGMPs.</li>\n\t<li>Notify Microbiology Laboratory management immediately of out of specification (OOS) results.</li>\n\t<li>Responsible for routine maintenance and preventative maintenance of laboratory equipment.</li>\n\t<li>Notify Microbiology Laboratory management of laboratory equipment problems or calibration issues.</li>\n\t<li>Responsible for reviewing and entering microbiological data into finished product batch records and other applicable laboratory documents (i.e. laboratory notebooks). &nbsp;Document and review of raw and final data to ensure complete and proper documentation according per procedures and applicable cGMPs.</li>\n\t<li>Responsible for maintaining and entering microbiological data (including Identification) into the Quality database and ensuring all data has been entered by review.</li>\n\t<li>Responsible for assisting with investigations for environmental monitoring excursions (action/alert level investigations), deviations, and OOS results as requested by the Microbiology Laboratory management.</li>\n\t<li>Responsible for the general maintenance and cleaning of the Microbiology Laboratory (including identification and warehouse areas) including good housekeeping and a safe working environment.</li>\n\t<li>Responsible for temperature monitoring, maintenance, and notification of calibration of laboratory equipment.</li>\n\t<li>Assist in regulatory audits as requested by Microbiology Laboratory Management.</li>\n\t<li>Assist in training of new employees on all applicable SOPs and tasks.</li>\n\t<li>Responsible for assisting with ordering and maintaining inventory of laboratory supplies including organization, labeling, and discard of materials.</li>\n\t<li>With guidance from Microbiology Laboratory management, assist in review of SOPs.</li>\n\t<li>Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.<br />\n\t&nbsp;</li>\n</ul>\n",
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