Qureos Mentor

Factor Health Marketing

SUMMARYThe Microbiologist supports and maintains product quality by being a key contributor in conducting, and reviewing microbiologic tests, applying concepts, practices, and procedures within the microbiology/sterile field and communicating results as a Microbiology Subject Matter Expert (SME).The Microbiologist will work with 503A operations. This is an on-site position in Ocala, FL.ESSENTIAL FUNCTIONS AND RESPONSIBILITIES<ul><li>Performs and reviews accurate release testing according to established SOPs, including but not limited to, sterility and endotoxin, visual inspection, etc.</li></ul><ul><li>Write/Review SOPs and Change Controls</li></ul><ul><li>Perform Environmental Monitoring of the cleanroom areas.</li></ul><ul><li>Perform testing in conjunction with laboratory investigations.</li></ul><ul><li>Draft microbiological reports, including but not limited to; Environmental Action reports, Protocols, Studies, Out of Specification Reports, Summary reports, etc.</li></ul><ul><li>Review and report data ensuring precise and accurate testing is performed.</li></ul><ul><li>Participate in method development and validation, if requested</li></ul><ul><li>Ensure that all sterile products are tested following regulatory requirements such as but not limited to: USP &lt;795&gt; &amp; &lt;797&gt;, cGMP</li></ul><ul><li>Sample result reading and data interpretation</li></ul><ul><li>Maintain documentation.</li></ul><ul><li>Review, trend and report environmental, personnel, in process, raw material, and finished product microbiological testing results.</li></ul><ul><li>Perform and review various microbiological procedures such as media qualifications, sterilizations, growth promotion tests and identification tests</li></ul><ul><li>Recognize, report and investigate any aberrant (Out of specification) test and/or sample conditions.</li></ul><ul><li>Maintain historical files on organisms found in classified areas; microbial identification and trending.</li></ul><ul><li>Support laboratory activities like media preparation, monitoring of incubators, refrigerators, etc.</li></ul><ul><li>Actively participate in investigations as microbiology Subject Matter Expert (SME)</li></ul><ul><li>Maintain and Manage the ATCC culture collection</li></ul><ul><li>Prepare and send samples for microbiological identification</li></ul><ul><li>Inspect, and review media fills and associated data</li></ul><ul><li>Keep informed of current scientific principles and theories</li></ul><ul><li>Initiate, complete and/or review OOS or Environmental Monitoring Excursion Investigations</li></ul><ul><li>Provide support of general QC Microbiology Laboratory activities such as; chart reading and changing, equipment cleaning and maintenance, maintain supplies and inventory and general laboratory housekeeping</li></ul><ul><li>Other duties may be assigned by management.</li></ul>QUALIFICATIONS AND SKILLS<ul><li>Bachelor&rsquo;s degree in Biology, Microbiology or appropriate discipline with at least 2-years experience, preferred.</li></ul><ul><li>Experience with OOS investigations/deviations/Non conformances, preferred.</li></ul><ul><li>Understanding of USP and Experience using aseptic techniques in GMP environment, preferred</li></ul><ul><li>Experience in reports for findings from FDA and state pharmacy board inspections.</li></ul><ul><li>Knowledge of different substances from small molecules to peptide, preferred.</li></ul><ul><li>Willing to travel 10 &ndash; 20% to other WPN sites.</li></ul><ul><li>Strong critical thinking skills</li></ul><ul><li>Excellent written and verbal communication skills</li></ul><ul><li>Strong leadership skills</li></ul><ul><li>Ability to multi-task and ensure deliverables are completed within designated time frame</li></ul><ul><li>Comfortable with public speaking</li></ul><ul><li>Excellent interpersonal skills</li></ul><ul><li>Any ASQ certification, preferred.</li></ul><ul><li>Knowledge of pharmaceutical regulations</li></ul><ul><li>Understanding of GMP requirements</li></ul><ul><li>Strong microbiology laboratory and microbiological technical knowledge in a pharmaceutical environment is required.</li></ul><ul><li>Knowledge of sterility methods; gamma, heat, chemical and/or filtration</li></ul><ul><li>Familiarity with Rapid Microbiological Detection methods, preferred</li></ul>Job Type: Full-timePay: $50,000.00 - $65,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Employee assistance program</li><li>Employee discount</li><li>Flexible spending account</li><li>Health insurance</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Application Question(s):<ul><li>Do you have stron microbiology laboratory and microbiological technical knowledge in a pharmaceutical environment? Required</li><li>Do you have a BS in Microbiology/Biology/Biochemistry or related sciences?</li><li>Do you have at least 2 &ndash; 3 years&rsquo; experience with gram stains, sub-culturing and identification of microorganisms and environmental monitoring?</li><li>Do you have experience with current practices and procedures used in microbiological and analytical laborator?</li><li>Do you have hands-on experience with microbiological investigations ?</li><li>Do you have good understanding of USP guidelines (&lt;71&gt;, &lt;797&gt;, &lt;795&gt;, &lt;800&gt;, &lt;61&gt;, &lt;62&gt;, &lt;51&gt;)?</li><li>Do you have good understanding of FDA Good Manufacturing Practices Regulations (GMP&rsquo;s), USP and OSHA safety requirements?</li><li>Do you have communication (both written and oral), interpersonal, team building and organizational skills?</li></ul>Work Location: In person

Quality Control Microbiologist

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Quality Control Microbiologist