Sr Associate QC - Microbiology (24/7 Shift)

<h2><b>Career Category</b></h2>Quality<h2></h2><h2><b>Job Description</b></h2><p>This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.<br/><br/><b>Specific Job Duties: </b></p><ul><li>Environmental Monitoring of Grade 8/9 Cleanrooms</li><li>Environmental Monitoring of Grade 5/7 Cleanrooms &amp; Isolators</li><li>Reading of Environmental Monitoring Plates</li><li>Bioburden testing of water &amp; disinfectants</li><li>Writing technical reports</li><li>Water sampling</li><li>Testing of In Process samples such as Protein Concentration, Density &amp; pH</li><li>Initiate and/or implement changes in controlled documents.</li><li>Participate in audits, initiatives, and projects that may be departmental or organizational in scope.</li><li>Write protocols and perform validation and equipment <span>qualification/verification.</span></li><li>Introduce new techniques to the lab, including method transfers, reports, validations and protocols.</li><li>Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.</li><li>Approve lab results.</li></ul><p></p><p><b>Basic <span>Qualifications: </span></b></p><ul><li>Bachelor's degree in a science discipline </li><li>Biopharmaceutical QC experience in a microbiology lab </li><li>Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products .</li></ul><p></p><p><b>Preferred Qualifications:</b> </p><ul><li>Experience working in an aseptic cleanroom performing Environmental Monitoring</li><li>Proficient in the use of LIMS &amp; LMES</li><li>Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery</li><li>Biopharmaceutical QC experience in a microbiology lab</li><li>Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products</li></ul><p><br/><b>Competencies </b></p><ul><li>Technically strong background in microbiology and aseptic manufacturing </li><li>Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage </li><li>Flexibility – the EM role often encounters changing priorities on a daily basis</li><li>Problem solving skills</li><li>Experience with Regulatory inspectors and interacting with inspectors desirable</li><li>Demonstrated ability to work independently and deliver right first time results</li><li>Works under minimal direction</li><li>Work is guided by objectives of the department or assignment</li><li>Follows procedures</li><li>Refers to technical standards, principles, theories and precedents as needed</li><li>May set project timeframes and priorities based on project objectives and ongoing assignments.</li><li>Recognizes and escalates problems</li><li>Auditing documentation and operation process</li><li>Demonstrated ability to interact with regulatory agencies.</li></ul><p></p><p></p><p></p>.