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Data Support Specialist BioA

Laboratory Corporation of America Holdings (Covance)

Chantilly, Virginia, United States

Job Overview:

The Data Support Specialist reviews laboratory data and study-related documentation to verify compliance with applicable protocols, Standard Operating Procedures (SOPs) and regulatory guidance (e.g. Good Laboratory Practices – GLPs). Maintains and monitors departmental trends in data quality and performs follow-up actions as needed by maintaining and communicating error tracking data in support of improvement efforts and performs follow up actions as needed. Reviews laboratory operations data, SOPs, and other study-related guidance documents to ensure quality standards are met and to verify conformance to applicable SOP, regulatory requirements, and overall client objectives. Assists internal customers with interpretation and understanding of regulatory requirements (e.g. GLPs), SOP requirements, and other guidance documents, as applicable. Maintains and seeks to expand a strong working knowledge of regulatory requirements, SOP requirements, and other guidance documents. Applies existing knowledge to data review tasks. Communicates regularly with internal laboratory operations personnel, scientific personnel, and management to effectively manage the quality review workload and timelines. Collects error tracking data for data reviewed and follows up with respondents, management, quality assurance, and others, if necessary, to ensure immediate resolution and to maintain and enhance data quality. Identifies and recommends procedural modifications in support of process improvements. Mentors less experiences staff and assists with the training of new quality review staff. Performs other relates duties as assigned.

Covance’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career. Education/Qualifications:Bachelor of Science/Arts (BS/BA) degree in chemistry, biology, biotechnology or related field Applicable experience may be substituted for education. Three (3) years of previous related experience may be substituted for BS/BA degree Working knowledge of GLPs Excellent attention to detail with strong organizational skills Efficient in prioritizing and managing time Proven ability to work under deadline pressure Demonstrated ability to interact effectively with internal customers Ability to efficiently us basic software (e.g. Word, Excel, PowerPoint) Experience:Two (2) years of laboratory, data review, or related experience required, including familiarity with laboratory processes and data.

Job posted: 2020-10-01

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