Laboratory Systems Validation Specialist

<h2>Job Overview:</h2><p style="margin-bottom: .0001pt;"><span style="font-family: arial, helvetica, sans-serif;"><strong><span style="font-size: 12pt;">Labcorp is looking for a Laboratory Systems Validation Specialist  to join our global team. </span></strong></span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10pt; font-family: verdana, geneva;"> </span></p><p style="margin-bottom: .0001pt;"><span style="font-size: 10pt; font-family: verdana, geneva;"><strong>Job responsibilities as a <span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Laboratory Systems Validation Specialist </span></strong><strong>include:</strong></span></p><p style="margin-bottom: .0001pt;"> </p><ul><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">The candidate should possess experience with laboratory instrument operation and/or interfaces, as well as LIS/LIMS, and/or Lab Middleware, such as Data Innovations’ Instrument Manager or Siemens’ CentraLink</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Provides insight and guidance while leading system validations for instrument, middleware and other laboratory systems.</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Provide operational support through support of change control process for instrument, middleware, and other laboratory systems.</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Responsible to participate in the assessment and description of, in close collaboration with the laboratory subject matter experts (SME), the expected behavior of the systems to automate some process steps and be able to translate them into formal requirements to whomever relevant (IT, person in charge of configuring rules...). These requirements will include potential changes/set-up needs outside of the middleware such as LIS to have the expected data workflow thanks to higher level understanding of data flow across systems</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Provides technical consults, as needed, for both internal and external clients</span></li></ul><p style="margin: 0px;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;"> </span></p><p style="margin-right: 4.3pt;"><strong><em><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Leadership duties and responsibilities:</span></em></strong></p><h4 style="margin: 0in 4.3pt .0001pt .5in;"><span><span style="font-size: 9.0pt; font-family: Symbol;">·       </span></span><span><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Ensures the collection of system requirements through communication with stakeholders and documentation of system requirements according to specified methodologies, </span></span></h4><h4 style="margin: 0in 4.3pt .0001pt .5in;"><span><span style="font-size: 9.0pt; font-family: Symbol;">·       </span></span><span><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Owns and produces appropriate validation documentation.  The ideal candidate possesses experience within a GxP and CAP/CLIA environment.  Experience with SDLC and/or GAMP is a plus.</span></span></h4><h4 style="margin: 0in 4.3pt .0001pt .5in;"><span><span style="font-size: 9.0pt; font-family: Symbol;">·       </span></span><span><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Responsible to develop and lead test efforts for a variety of laboratory workflow and physical automation and lab instrument middleware platforms</span></span></h4><h4 style="margin: 0in 4.3pt .0001pt .5in;"><span><span style="font-size: 9.0pt; font-family: Symbol;">·       </span></span><span><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Responsible to lead requirement gathering efforts for middleware interface development efforts.</span></span></h4><h4 style="margin: 0in 4.3pt .0001pt .5in;"><span><span style="font-size: 9.0pt; font-family: Symbol;">·       </span></span><span><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Works with GLSS and IT project managers and resources owners to coordinate resources for system test efforts</span></span></h4><h4 style="margin: 0in 4.3pt .0001pt .5in;"><span><span style="font-size: 9.0pt; font-family: Symbol;">·       </span></span><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Responsible for driving overall performance and delivery of on-time services</span></h4><h4 style="margin: 0in 4.3pt .0001pt .5in;"><span><span style="font-size: 9.0pt; font-family: Symbol;">·       </span></span><span><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.</span></span></h4><ul><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Responsible for ensuring client satisfaction</span></li></ul><p style="margin: 0px;"><strong><em><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;"> </span></em></strong></p><p style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;"> </span></p><p style="margin: 0px;"><strong><em><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Performance Monitoring and Evaluation</span></em></strong></p><ul><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Responsible to monitor execution of system testing according to specified metrics, identifies and resolves issues and challenges; escalates issues as needed.</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Accountable for the pre-QA evaluation and treatment of system test results, ensuring appropriate and complete test packages for each system effort in which he/she is involved.</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Responsible for timely and efficient work output within each functional area in accordance with Covance quality standards.</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Responsible to balance operational support assignment with at least one active project assignments. </span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Ensures resources are sufficient to meet established performance and quality goals</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Ensures regulatory compliance</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Collaborate between the local department unit and counterparts at other sites and with other functional areas </span></li></ul><p style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;"> </span></p><p style="margin: 0px;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;"> </span></p><h4 style="margin: 0in 4.3pt .0001pt .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Duties and Responsibilities General</span></h4><ul><li style="margin: 0in 4.3pt .0001pt .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Perform duties of qualification specialist roles as needed in times of high customer demand.</span></li><li style="margin: 0in 4.3pt .0001pt .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Coordinates the review, approval, and retention of validation documentation</span></li><li style="margin: 0in 4.3pt .0001pt .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Provides written and verbal reports to project managers and/or GLSS leadership</span></li><li style="margin: 0in 4.3pt .0001pt .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Responsible to execute all HR and training-related personnel tasks as defined by the company and department</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Provide a monthly report to the Manager</span></li><li style="margin-left: .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Individual is responsible for maintaining his/her complete up-to-date training file. Individual is responsible for ensuring he/she is trained and training is documented prior to performing a task. Individual is accountable for any deficiencies found in his/her training file.</span></li><li style="margin: 0in 4.3pt .0001pt .5in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Support a culture of continuous improvement, quality and productivity</span></li></ul><h2>Education/Qualifications:</h2><h2 style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Minimum Required:</span></h2><ul><li style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: #333333;">Bachelor of Science (BS) or higher degree in a related area of study</span></li><li style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: #333333;">Background in information systems, data analysis, workflow analysis</span></li><li style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: #333333;">Ability to effectively communicate with our clients at all levels of the organizations and primarily within the laboratory</span></li></ul><h2>Experience:</h2><h2><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Minimum Required:</span></h2><ul><li style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: #333333;">3 to 5 years experience in a Laboratory System Analyst or Laboratory System Validations role (or similar experience). </span></li><li style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif;">Experience in IT/Computer validation (to leverage important inputs on how to handle the workflow, how to avoid data integrity problems, evaluate upfront solutions with less validation effort and capture any event possibility required by a system when setting complex rules)</span></li><li style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: #333333;">Experience as a Business Analyst / requirements gathering, documentation in a regulatory environment</span></li><li style="margin-left: .25in;"><span style="font-size: 9.0pt; font-family: 'Tahoma',sans-serif; color: #333333;">Strong knowledge of 21 CFR Part 11 requirements and CAP/CLIA regulations</span></li></ul>