Senior QC Specialist

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: verdana, geneva; font-size: 12pt;"><strong>Why Covance:</strong></span></p><ul><li><span style="font-family: verdana, geneva; font-size: 12pt;">Work for the best Central Laboratory services in the world</span></li><li><span style="font-family: verdana, geneva; font-size: 12pt;">Dynamic and collaborative team, with supportive leadership</span></li><li><span style="font-family: verdana, geneva; font-size: 12pt;">Competitive compensation and benefit</span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0in 0in 0pt;"><strong><span style="font-family: verdana, geneva;"><span style="font-size: 14.6667px;">Role at a Glance:</span></span></strong></p><p style="padding-left: 40px;"><span style="font-family: verdana, geneva;"><span style="font-size: 11pt;">The role ensures that compliance and scientific standards are met within the department by reviewing departmental data for scientific integrity and compliance to applicable Standard Operating Procedures (SOPs) and regulations. Initiates and facilitates quality improvement objectives throughout the department. Monitors departmental systems and trends in eQA and performs follow up actions as needed. Maintains and communicates error tracking data in support of departmental improvement efforts.</span></span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: verdana, geneva;"><strong><span style="font-size: 11pt;">Duties and Responsibilities</span></strong><span style="font-size: 11pt;">:</span></span></p><ul><li style="color: #000000;"><span style="font-size: 11pt; font-family: verdana, geneva;">Takes a lead role in guiding co-workers and internal customers with interpretation of regulatory requirements (e.g., GLPs), SOP requirements, and other guidance documents, as applicable.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Possesses a strong understanding of departmental processes and acts as a consultant for improving compliance within the department.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Reviews data to ensure that quality standards are met and to verify compliance to applicable SOP and regulatory requirements. Utilizes scientific judgment to ensure scientific soundness and integrity of data reviewed. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Maintains working knowledge of client SOPs and requirements as applicable. Ensures that data meet applicable client SOPs and requirements. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Independently schedules and performs audits of departmental systems and supporting data, as applicable, to ensure proper documentation and maintenance (e.g. training files, client SOP reading lists, logbooks, etc.).   </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Collects error tracking data for items reviewed and reports trends as feedback to the department.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Monitors citation trends in eQA and performs follow-up actions with respondents, management, or others, if needed, to prevent recurring citations, problems, or errors.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Promotes quality and regulatory compliance within the department by working with operations and scientific staff to resolve service/quality issues, serving on a committee, assisting with the development of training programs related to documentation and quality, or other related involvement.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Notifies management of observed quality/compliance issues and service failures.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Participates in and guides quality improvement opportunities and optimization efforts to promote best practices. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Participates in project debrief meetings or client visits as needed.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Facilitates changes to SOPs, policies, training materials, and other documents as applicable. </span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Mentors less experienced QC staff.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Completes self-development opportunities.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-family: verdana, geneva;"><span style="font-size: 11pt;">P</span><span style="font-size: 11pt;">er</span><span style="font-size: 11pt;">forms other related duties as assigned.</span></span></li></ul><p style="margin: 0px;"><span style="font-family: verdana, geneva;"><strong><span style="font-size: 11pt;">Principal Contacts:</span></strong></span></p><ul><li style="color: #000000;"><span style="font-size: 11pt; font-family: verdana, geneva;">Interacts internally with operations personnel, scientific personnel, and departmental management. May interact with internal Covance QA. May interact with external clients.</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="color: #000000;"><span style="font-size: 11pt; font-family: verdana, geneva;">Bachelor of Science/Arts (BS/BA) degree.</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 11pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Ability to efficiently use basic software (e.g., Word, Excel, PowerPoint).</span></li><li style="color: #000000; font-family: 'Times New Roman',serif; font-size: 10pt;"><span style="font-size: 11pt; font-family: verdana, geneva;">Experience may be substituted for education. For example, a two-year Associate degree plus 2 years applicable experience may be substituted for a BS/BA degree</span></li></ul><h2>Experience:</h2><ul><li style="color: #000000;"><span style="font-size: 11pt; font-family: verdana, geneva;">Four years of laboratory or data review experience with a BS/BA degree.</span></li></ul>