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    "requisitionDescription": "<div><div><p style=\"margin-left:0in;\" data-pasted=\"true\"><strong>Job Title:</strong> QC Manager</p><p style=\"margin-left:0in;\"><strong>Department:</strong> Quality Control - Analytical</p><p style=\"margin-left:0in;\"><strong><u>GENERAL DESCRIPTION:</u></strong></p><ul style=\"list-style-type: disc;\"><li>QC Manger is responsible for overseeing a team of QC Analysts and is also responsible for maintaining the QC Laboratory in a state of cGMP compliance.<u><br></u><strong><u><br></u></strong><strong><u>DUTIES AND RESPONSIBILITIES:&nbsp;</u></strong></li></ul><ul type=\"disc\"><li>Training, coaching, and development of QC staff</li><li>Develop, revise, and review SOPs, qualification/validation protocols and reports.</li><li>Write deviations, CAPA&rsquo;s and own change controls.</li><li>Review/Provide guidance for deviations/CAPA&rsquo;s generated by QC Analysts</li><li>Responsible for reviewing invalid assays and lead invalid assay investigations</li><li>Participating in OOS investigations</li><li>Responsible for ensuring all analytical data generated by QC lab to be initiated on time and completed within established TAT&rsquo;s.</li><li>Perform review of QC documentation (equipment logbooks, sol&rsquo;n prep record, cell line records, TRF&rsquo;s, etc)</li><li>Ensure test results are entered into the appropriate reports&nbsp;</li><li>Track/Trend Ref. Std, Assay Control and Critical Reagents</li><li>Track equipment cleaning/PM/Calibration schedules&nbsp;</li><li>Review equipment IOQ&rsquo;s and Re-Qualifications&nbsp;</li><li>QC Process/Procedure continuous improvements&nbsp;</li><li>Perform other duties as needed</li></ul><p style=\"margin-left:.5in;\"><strong><u>EDUCATION AND EXPERIENCE:</u></strong></p><ul type=\"disc\"><li>BS degree in the Biological Sciences, Bioengineering, or Chemistry.</li><li>7+ years of experience performing QC activities in the pharmaceutical and biotech industry under GMP guidelines, with demonstrated expertise in multiple disciplines and assays.&nbsp;</li><li>2+ years of supervisory experience.</li><li>Advanced experience with QC testing in pharmaceutical or biopharmaceutical laboratories</li><li>Familiarity with analytical testing procedures: qPCR, HPLC, ELISA, Cell-based Assays, etc.</li></ul><p style=\"margin-left:.5in;\"><br></p><p style=\"margin-left:0in;\"><strong><u>DESIRED KEY COMPETENCIES</u></strong>:</p><ul type=\"disc\"><li>Demonstrated ability to manage a team and work independently on projects, and review project data and provide summary analysis reports based upon the data</li><li>Ability to provide support for regulatory and client audits, as well as interact with clients.</li><li>Ability to effectively negotiate and build collaboration amongst individuals.</li><li>Ability to be self-motivated, proactive, accountable, and flexible</li><li>Demonstrate the ability to develop, coach and mentor key employees.</li><li>Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.</li><li>High attention to detail, highly organized, and excellent documentation skills</li><li>Strong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve them</li><li>Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on upon changing priorities.</li></ul><p style=\"margin-left:0in;\"><br></p></div></div>\n",
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