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Data Quality Control Specialist

Company: Labcorp Drug Development
Location: Somerset
Posted on: September 24, 2022

Job Description:

Explore research careers and be a part of something bigger!Are you interested in quality, compliance and accuracy? - Are you detailed oriented and have experience in reviewing for Quality - and Regulatory standards?Labcorp Drug Development helps to develop new drugs, medical devices and diagnostics. Your role is vital to improving the health of family, friends and animals.We are looking for a Data Quality Control Specialist to join our Labcorp Drug Development -site located in Somerset, NJ. The Data Quality Control Specialist is part of a division that supports preclinical work and safety studies as part of the drug development process.Reviews data for accuracy and compliance to applicable Standard Operating Procedures (SOPs), protocols and regulatory guidelines. - Maintains and expands knowledge of regulatory requirements, protocol requirements, SOP requirements, and client requirements. - Responds to Quality Assurance inspection reports. - Maintains discrepancy tracking data in support of departmental improvement efforts. -To collect, document, and manage pertinent data including animal observations, test material administration, and clinical sample collection in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines. - To monitor animal health and welfare in compliance with the Animal Welfare Act and help maintain facilities for AAALAC complianceLearns to review data to assure quality standards are met and to verify compliance to applicable SOP and regulatory requirements.Seeks to expand knowledge of regulatory requirements (e.g. GLPs), SOP requirements, and other guidance documents. - Applies existing knowledge to data review tasks. -Learns to collect discrepancy tracking data for items reviewed.Learns to utilize the Toxicology Data Collection and Reporting System for review of electronic data.Has the ability to understand and interpret complex protocols.Learns to identify discrepancy trends and shares results with management.Responds to QA inspection report findings related to review of data.Assess and document clinical observations, body weight data, food consumption data, environmental data, and other data on the appropriate data collection system (or by hand when necessary).Recognizes deviations from expected results and takes appropriate action.Works with others to resolve discrepancies before they become deviations.Effectively schedules multiple assignments.May help in lab as needed to maintain skills and keep up with SOP changes.Other duties as assignedLabcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.For more information about how we collect and store your personal data, please see our -Privacy Statement. -Job SummaryJob number: 2256694Date posted : 2022-09-12Profession: Regulatory/ComplianceEmployment type: Full-Time

Keywords: Labcorp Drug Development, Trenton , Data Quality Control Specialist, Other , Somerset, New Jersey

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