Quality Assurance Specialist 1

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    "requisitionDescription": "<div><p style=\"margin-left:17.1pt;\"><strong>Job Function</strong></p><p style=\"margin-left:17.1pt;\" data-pasted=\"true\">The <strong>&nbsp;Quality Systems Specialist</strong> is primarily responsible for the following:</p><ul style=\"list-style-type: disc;margin-left: 0.25in;\"><li>Designs, develops, and implements internal auditing programs and procedures consistent with the organization&rsquo;s requirements</li><li>Performs Internal Audits, to ensure that procedures are available and adhered to according to requirements for maintaining ISO/IEC 17025:2017 accreditation and GLP (Good Laboratory Practices) recognition.</li><li>Performs GLP inspections to ensure that GLP studies are completed according to OECD and/or FDA GLP requirements.</li><li>Reports audit findings to Director QA or designate and conducts post-audit meetings as necessary.</li><li>Performs/ reviews non-conformance investigations to ensure the non-conformance has been addressed and full and proper resolution has been documented.</li><li>Issues corrective actions in response to Quality Systems activities, tracking the progress and verifying the implementation and effectiveness of corrective actions</li><li>Completes evaluation of supplier quality</li><li>Arranges and prepares for external audits, assists with pre and post-assessment activities. Coordinates necessary action on audit findings corrective/preventive actions, and responds to related findings externally.</li><li>Reviews/ Evaluates laboratory performance in Proficiency testing/ Inter-laboratory studies</li><li>Coordinates/ performs refresher training (ISO 17025 and GMP) for laboratory staff.</li><li>Reports quality metrics regularly to top management&nbsp;</li><li>Responsible for quality projects as assigned</li></ul><p><strong>Primary Responsibilities&nbsp;</strong></p><ul><li>schedule and perform internal audits</li><li>Participate in external audits</li><li>review and investigate non-conformances, client complaints</li><li>Issue and monitor corrective actions</li><li>Evaluate supplier quality</li><li>Review, approve, and maintain equipment qualification records</li><li>Perform Administrative Tasks</li><li>The employee shall implement the Laboratory Quality Policy and perform their duties in accordance to existing job specific requirements and procedures</li><li>Compliance to Health &amp; Safety policies and procedures; wear required Personal Protective equipment at all times while in the laboratory</li><li>Other duties as assigned</li></ul><p><strong>Education</strong></p><ul type=\"disc\" data-pasted=\"true\"><li>Minimum Bachelor of Science in a technical discipline (Chemical or Biological Sciences)</li></ul><p><strong>Experience</strong></p><ul><li>3+ years experience in an auditor role in ISO 17025 accreditation, GLP and/or GMP regulated environment, with proficiency in quality assurance systems and documentation</li><li>Excellent attention to detail, organizational, prioritization and problem-solving skills&nbsp;</li><li>Technical experience in the use, calibration of various analytical instrumentation commonly found in a commercial laboratory.</li><li>Proficient in written and spoken English.&nbsp;excellent communication, conflict resolution</li><li>Proficient in MS Office (Excel, Outlook, Word); Computer literate. Familiarity with IT systems, electronic submission systems, data and document management system</li><li>Or as determined by Human Resources and Department Manager/Supervisor</li></ul></div>\n",
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