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Quality Associate - Good Manufacturing Practice (GMP)

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; background-color: #ffffff;"≥<strong≥Are you interested in starting a career as a trainee Quality Assurance professional? </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 work in the Pharmaceutical/Drug Development industry?</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 work for 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;"≥As one of the world’s premier Contract Research Organisations, we provide research services for a multitude of organisations.</span≥</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥We strive to make a difference to people’s everyday lives by bringing essential products to the market and as a Quality Associate at Covance by 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;"≥<span style="color: #000000; font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥The Quality Associate is responsible for supporting the local implementation and operation of the GMP Quality Management System. The role aims to ensure the site remains in a state of GMP compliance by participation in investigations, audits, data reviews, validation projects and the delivery of GMP related training, etc. This role is a trainee position; therefore, the following duties will require training/supervision:                                                             </span≥</p≥<p style="margin: 0px;"≥ </p≥<p style="margin: 0px;"≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥<strong≥Responsibilities will include:</strong≥</span≥</p≥<ul≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Performs a preliminary regulatory review to provide recommendations regarding the compliance status of study related documentation (i.e. protocols, reports, certificates of analysis, etc) prior to QA approval</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Reviews and approves site quality documents (Standard Operating Procedures (SOP's), Policies, etc.) to ensure compliance with GMP, Covance document management procedures and other applicable quality standards</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Supports the GMP QA internal audit programme by participating as trainee in audits of GMP-related systems, processes and facilities</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Participates in projects as trainee to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Review of metrology methods and specifications for accuracy/relevance and compliance with appropriate standards</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Participates as a trainee in investigations (deviations, OOS, customer complaints, etc.) assisting senior GMP QA personnel to assign cause and resolution of quality defects</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Participates as a trainee to continual improvement initiatives aimed at improving the efficiency/ effectiveness of GMP operations</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Delivery of basic GMP training in due course</span≥</li≥</ul≥<h2≥Education/Qualifications:</h2≥<ul≥<li≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥A minimum of a Bachelors Degree or equivalent in a Pharmacy, Chemistry or Biology related discipline.</span≥</li≥</ul≥<h2≥Experience:</h2≥<ul≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Good communication, decision making, negotiating, and problem solving skills</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Experience in GMP / GLP or simmilar regulations - likley from a lab environment.</span≥</li≥<li≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Customer service orientated, i.e. ability to interact effectively with clients</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Experience in process improvement preferable</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Ability to work under minimal supervision</span≥</li≥<li≥<span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"≥Computer literate</span≥</li≥<li≥<span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"≥Good verbal and written communication in English</span≥</li≥</ul≥

Job posted: 2021-01-15

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