QC reviewer II BioA

<h2>Job Overview:</h2><p style="margin: 0px;">Ensures that compliance standards are met within the department by reviewing departmental data and reports for accuracy and compliance to applicable Standard Operating Procedures (SOPs) and regulations.  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. </p><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><ol><li style="margin-left: 0in;"><strong><span style="font-size: 11.0pt;">Duties and Responsibilities</span></strong><span style="font-size: 11.0pt;">:</span></li></ol><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Assists 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="margin-left: .25in;"><span style="font-size: 11.0pt;">Reviews data to ensure quality standards are met and to verify compliance to applicable SOP and regulatory requirements.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Maintains working knowledge of client SOPs and requirements as applicable. Ensures that data reviewed meets applicable client SOPs and requirements. </span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Performs regularly scheduled 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="margin-left: .25in;"><span style="font-size: 11.0pt;">Collects error tracking data for items reviewed and reports trends as feedback to the department.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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="margin-left: .25in;"><span style="font-size: 11.0pt;">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="margin-left: .25in;"><span style="font-size: 11.0pt;">Notifies management of observed quality/compliance issues and service failures.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Participates in quality improvement opportunities and harmonization efforts to promote best practices. </span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Participates in project debrief meetings as needed.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Facilitates changes to SOPs, policies, training materials, and other documents as applicable. </span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Completes self-development opportunities.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Performs other related duties as assigned.</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><ol><li style="margin-left: 0in;"><strong><span style="font-size: 11.0pt;">Principal Contacts:</span></strong></li></ol><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Interacts internally with operations personnel, scientific personnel, and departmental management. May interact with internal Covance QA.  May interact with external clients.</span></li></ul><p style="margin: 0px;"><span style="font-size: 11.0pt;"> </span></p><ol><li style="margin-left: 0in;"><strong><span style="font-size: 11.0pt;">Travel Requirements: </span></strong></li></ol><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Yes, <5.0% of the time for potential cross-site QC support needs or external training needs. </span></li></ul><p style="margin: 0px;"><strong><span style="font-size: 11.0pt;"> </span></strong></p><ol><li style="margin-left: 0in;"><strong><span style="font-size: 11.0pt;">Language Skills Required:</span></strong></li></ol><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Speaking: Yes English</span></li><li style="margin-left: .25in;"><span style="font-size: 10pt;">Writing/Reading: Yes English</span></li></ul><h2>Education/Qualifications:</h2><ul><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Bachelor of Science/Arts (BS/BA) degree.</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">Ability to efficiently use basic software (e.g., Word, Excel, PowerPoint).</span></li><li style="margin-left: .25in;"><span style="font-size: 11.0pt;">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="margin-left: .25in;"><span style="font-size: 11.0pt;">Two years of laboratory, data review, or related experience with a BS/BA degree.</span></li></ul>