Microbiology Analyst I

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    "description_html": "<p>&nbsp;&nbsp;</p><p><strong>Job Purpose:&nbsp;</strong></p><p>The QC Microbiology Analyst I 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. Must demonstrate a high level of proficiency in Microbiology testing. &nbsp;</p><p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</p><p><strong>Essential Duties and Responsibilities:</strong></p><p>· Applies quality scientific techniques in the microbiological analysis of raw materials; in-process &amp; finished product samples to include: sterility, bioburden, identification, environmental monitoring, growth promotion, microbial recovery and media fill tests following approved procedures.&nbsp;</p><p>· Notifies Microbiology management of all OOS and OAL testing results.&nbsp;</p><p>· Provides feedback on SOPs, forms, logbooks, etc., as necessary, to facility ever-changing expectations for operating procedures and testing-related information. &nbsp;</p><p>· Performs routine testing of products to support release and company needs.</p><p>· Trains fellow QC laboratory personnel on QC test methods.&nbsp;</p><p>· Demonstrates ability to understand and interpret test results in relation to acceptance or rejection of lot tested.</p><p>· Generates data, as needed, for investigations; performs data entry for various systems and processes, and understands the necessity of trending reports&nbsp;</p><p>· Reports and initiates documentation and communication of OOS and OOT results and investigation reports.</p><p>· Assists the Sample Management team with sample receiving and waste destruction, as needed.</p><p>· Performs method validation testing if requested by supervisor.</p><p>· Performs general laboratory housekeeping and upkeep of various testing stations.</p><p>· Communicates all Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to QC Microbiology Shift Lead, QC Microbiology Supervisor, QC Microbiology Operations Manager, Director of Microbiology, or designee. &nbsp;</p><p><strong>Supplemental Functions:&nbsp;</strong></p><ul><li>Performs other duties as assigned.</li></ul><p><strong>Job Specifications and Qualifications:&nbsp;</strong></p><p><strong>Knowledge &amp; Skills:&nbsp;</strong></p><ul><li>2 – 4 years of experience with Microsoft Office programs, as well as the ability to learn new systems and computer software programs effectively and efficiently required. &nbsp;</li><li>Experience with cGMP documentation systems and with implementation of quality control systems. &nbsp;</li><li>Strong interpersonal, verbal, and written communication skills; effectively multi-tasking and problem solving skills. &nbsp;&nbsp;</li><li>Must maintain flexibility in the assignments of tasks, and be open to receive and provide training in multiple areas. &nbsp;&nbsp;</li><li>Knowledge of FDA manufacturing/regulatory quality systems regulations, qualifications, facilities, and requirements. &nbsp;</li><li>Accepting of new changes in order to achieve department demands. &nbsp;</li><li>Must possess effective written and oral communication skills and be able to handle multiple tasks within limited time frames.&nbsp;</li><li>Aseptic technique and familiarity with cGMPs and regulatory requirements is required.&nbsp;</li><li>Specific expertise, skills and knowledge within microbiology gained through education and experience.&nbsp;</li><li>A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities.&nbsp;</li><li>The ability to take strategic objectives and accept accountability to drive results through effective actions.&nbsp;</li><li>The ability and willingness to change direction and focus to meet shifting organizational and business demands.&nbsp;</li><li>The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;development goals.&nbsp;</li><li>Position requires bending, typing, lifting, reaching, vision, standing (50%), sitting (10%), walking (20%), and hearing.&nbsp;</li><li>Incumbents required to wear safety glasses, gloves, laboratory coats and other non-specified protective equipment as &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;necessary.&nbsp;</li></ul><p><strong>Education/Experience:&nbsp;</strong></p><ul><li>Regionally accredited Bachelor’s Degree in Biology, Microbiology, or Life Sciences, required; Master’s degree, preferred. &nbsp;</li></ul><p>· At least 1-year experience working directly with Pharmaceutical Microbiology methods. &nbsp;</p><p>· 1 – 2 years of experience in general laboratory skills and a knowledge of aseptic technique. &nbsp;</p><p>&nbsp;&nbsp;&nbsp;&nbsp;</p><p><strong>Working Conditions / Physical Requirements:</strong></p><ul><li>This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.</li></ul><p>· Hours of work: 12-hour rotating shifts. &nbsp;</p><p>· Salary range: Based on experience.&nbsp;</p>",
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      "description": "<p>Description</p><p>  </p><p><strong>Job Purpose: </strong></p><p>The QC Microbiology Analyst I 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. Must demonstrate a high level of proficiency in Microbiology testing.  </p><p>      </p><p><strong>Essential Duties and Responsibilities:</strong></p><p>· Applies quality scientific techniques in the microbiological analysis of raw materials; in-process & finished product samples to include: sterility, bioburden, identification, environmental monitoring, growth promotion, microbial recovery and media fill tests following approved procedures. </p><p>· Notifies Microbiology management of all OOS and OAL testing results. </p><p>· Provides feedback on SOPs, forms, logbooks, etc., as necessary, to facility ever-changing expectations for operating procedures and testing-related information.  </p><p>· Performs routine testing of products to support release and company needs.</p><p>· Trains fellow QC laboratory personnel on QC test methods. </p><p>· Demonstrates ability to understand and interpret test results in relation to acceptance or rejection of lot tested.</p><p>· Generates data, as needed, for investigations; performs data entry for various systems and processes, and understands the necessity of trending reports </p><p>· Reports and initiates documentation and communication of OOS and OOT results and investigation reports.</p><p>· Assists the Sample Management team with sample receiving and waste destruction, as needed.</p><p>· Performs method validation testing if requested by supervisor.</p><p>· Performs general laboratory housekeeping and upkeep of various testing stations.</p><p>· Communicates all Microbiology-related observations, issues, problems, discrepancies, and any violation of company policies or procedures to QC Microbiology Shift Lead, QC Microbiology Supervisor, QC Microbiology Operations Manager, Director of Microbiology, or designee.  </p><p><strong>Supplemental Functions: </strong></p><ul><li>Performs other duties as assigned.</li></ul><p><strong>Job Specifications and Qualifications: </strong></p><p><strong>Knowledge & Skills: </strong></p><ul><li>2 – 4 years of experience with Microsoft Office programs, as well as the ability to learn new systems and computer software programs effectively and efficiently required.  </li><li>Experience with cGMP documentation systems and with implementation of quality control systems.  </li><li>Strong interpersonal, verbal, and written communication skills; effectively multi-tasking and problem solving skills.   </li><li>Must maintain flexibility in the assignments of tasks, and be open to receive and provide training in multiple areas.   </li><li>Knowledge of FDA manufacturing/regulatory quality systems regulations, qualifications, facilities, and requirements.  </li><li>Accepting of new changes in order to achieve department demands.  </li><li>Must possess effective written and oral communication skills and be able to handle multiple tasks within limited time frames. </li><li>Aseptic technique and familiarity with cGMPs and regulatory requirements is required. </li><li>Specific expertise, skills and knowledge within microbiology gained through education and experience. </li><li>A broad perspective that aligns decisions to organizational objectives and long term consequences of day-to-day activities. </li><li>The ability to take strategic objectives and accept accountability to drive results through effective actions. </li><li>The ability and willingness to change direction and focus to meet shifting organizational and business demands. </li><li>The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve      development goals. </li><li>Position requires bending, typing, lifting, reaching, vision, standing (50%), sitting (10%), walking (20%), and hearing. </li><li>Incumbents required to wear safety glasses, gloves, laboratory coats and other non-specified protective equipment as      necessary. </li></ul><p><strong>Education/Experience: </strong></p><ul><li>Regionally accredited Bachelor’s Degree in Biology, Microbiology, or Life Sciences, required; Master’s degree, preferred.  </li></ul><p>· At least 1-year experience working directly with Pharmaceutical Microbiology methods.  </p><p>· 1 – 2 years of experience in general laboratory skills and a knowledge of aseptic technique.  </p><p>    </p><p><strong>Working Conditions / Physical Requirements:</strong></p><ul><li>This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.</li></ul><p>· Hours of work: 12-hour rotating shifts.  </p><p>· Salary range: Based on experience. </p>",
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