Lab Systems Qualification Specialist I

<h2≥Job Overview:</h2≥<p style="margin: 0px;"≥<span style="font-size: 12pt;"≥We are seeking a Lab Systems Qualification Specialist I to support our lab in Indianapolis.  Duties will include the following:</span≥</p≥<p style="margin: 0px;"≥ </p≥<ul≥<li≥<span style="font-size: 12pt;"≥Responsible to create, review and sign off laboratory instruments qualification documents.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Responsible to create, review and sign off laboratory instrument platform validation plans.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Responsible to create, review and sign off laboratory instrument product configuration specifications.</span≥</li≥<li≥<span style="font-size: 12pt;"≥ Responsible to create, review and sign off laboratory change requests for instruments.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Responsible to liaise with laboratory operation subject matter expert and instrument engineers to gather appropriate instrument qualification documents and certification/training documents from the vendor.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Responsible to train and support laboratory operation in all sites on instrument activities managed by LSQS 1 role.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Responsible to maintain and store documentation in designated documentation management system.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Responsible to recommend the necessary instrument procedural changes to ensure compliance; closes any gap that may exist as well as remediation plan where it is required.</span≥</li≥<li≥<span style="font-size: 12pt;"≥With Managers, and other laboratory staff, completes all instrument documentation for regulatory compliance; through training and auditing of processes, ensures that compliance is achieved. Works with QA Staff to ensure that compliance is sustained.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Works with IT to help bring instruments into production.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Develops and maintains competency in spreadsheet assessment process.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Supports internal and external audit requests for site as needed.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Maintains highest standards for Covance CLS in area of regulatory compliance.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Participates in continuing education activities to keep knowledge current.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Demonstrates and documents competency as appropriate for regulatory requirements.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Maintains a high degree of safety awareness; observes Universal Precautions procedures.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Maintains areas/activities in inspection ready condition.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Maintains an up-to-date training file. Responsible for assuring that training is received and is documented prior to performing an assignment. Responsible for accuracy of training file and is accountable for any deficiencies found.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Demonstrates advanced use and knowledge of computer systems.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Provides laboratory management with a monthly report of activities at minimum.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Other duties as assigned.</span≥</li≥</ul≥<h2≥Education/Qualifications:</h2≥<p style="margin: 0px;"≥<span style="font-size: 12pt;"≥Bachelor level degree or Medical Technologist diplomas.</span≥</p≥<h2≥Experience:</h2≥<p style="margin: 0px;"≥<span style="font-size: 12pt;"≥Minimum qualifications:</span≥</p≥<ul≥<li≥<span style="font-size: 12pt;"≥1-2 of experience with laboratory instruments in regulated setting.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Strong knowledge of CAP/CLIA, GCP, and other applicable regulations.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Has good customer service skills and great attention to detail.</span≥</li≥</ul≥<p style="margin: 0px;"≥<span style="font-size: 12pt;"≥Preferred:</span≥</p≥<ul≥<li≥<span style="font-size: 12pt;"≥Medical Technologist background.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Instrument qualification or system validation experience.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Proven initiative and ability to work collaboratively within teams and achieve results.</span≥</li≥<li≥<span style="font-size: 12pt;"≥Fluent in English, French a good asset </span≥</li≥<li≥<span style="font-size: 12pt;"≥Excellent written, verbal, and strong interpersonal skills.</span≥</li≥</ul≥