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GLP Quality Assurance Auditor

Laboratory Corporation of America Holdings (Covance)

Harrogate, United Kingdom

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Are you already working in a GLP / GCP environment and want to consider Quality Assurance as your next career move?</strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Do you want to be part of a company that helps build a healthier and safer world?</strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Are you looking for industry recognised training and development opportunities?</strong></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="color: #0a0a0a; font-family: arial, helvetica, sans-serif; font-size: 12pt;">Labcorp is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">As a <strong>Good Laboratory Practice (GLP) Quality Assurance Auditor</strong> at Labcorp, based at Harrogate, North Yorkshire you will play an essential part in making this happen.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsibilities will include:</span></strong></p><p style="margin: 0px;"> </p><ul><li style="color: #000000;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Performing protocol, data, report, and in-lab phase inspections for a specific study type to verify conformance to applicable Standard Operating Procedures (SOP's) and GLP regulatory requirements.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt; margin-top: 0in; margin-bottom: 0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Evaluating responses to GLP inspection reports and performing follow-up with respondents, management, or others, if needed, to ensure resolution.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt; margin-top: 0in; margin-bottom: 0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensuring that systems used in GLP quality assurance are properly maintained.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt; margin-top: 0in; margin-bottom: 0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Notifiying management of service failures.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt; margin-top: 0in; margin-bottom: 0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Performing study sign-off including but not limited to quality assurance statement preparation (internal/external) and report finalisation.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt; margin-top: 0in; margin-bottom: 0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Performing Standard Operating Procedure (SOP) reviews.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt; margin-top: 0in; margin-bottom: 0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Participating in internal facility and supplemental inspections, under supervision.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt; margin-top: 0in; margin-bottom: 0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Deliver basic GLP quality/regulatory training, under supervision.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt; margin-top: 0in; margin-bottom: 0pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Identifying opportunities for process improvement and harmonisation efforts that promote best practices.</span></li></ul><p style="margin: 0px;"> </p><p style="margin-bottom: 0.0001pt; text-align: justify;"><strong><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">What Labcorp can offer you:</span></strong></p><p style="margin-bottom: 0.0001pt; text-align: justify;"> </p><ul style="text-align: justify;"><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Competitive salaries and a comprehensive benefits package including health cover and contributory pension.</span></li><li><span style="font-size: 12.0pt; font-family: 'Arial',sans-serif;">Unrivalled opportunities to develop a successful career in the scientific industry.</span></li><li><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Unsurpassed career development opportunities.</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience).</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience may be substituted for education.</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Proven work history in a regulatory environment.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to apply basic relevant regulatory knowledge - GLP/GCP.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to follow instruction e.g. QA documents (SOPs).</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to assimilate/interpret operational documents such that audit can be performed to required level.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to critically assess data and apply procedures and regulations.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Adaptability to an ever changing work environment.</span></li><li><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ability to recognise gaps in procedures and regulations and consult with more senior QA individuals.</span></li></ul>

Job posted: 2021-09-07

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