Laboratory Systems Validation Coordinator (LSVC) I

Responsible to create, review and sign off laboratory instruments qualification documents. Responsible to create, review and sign off laboratory instrument platform system validation deliverables following corporate system development life-cycle. Responsible to create, review and sign off instrument platform User Requirement Specification as part of the system development life-cycle. Responsible to create, review and sign off instrument platform user acceptance testing and managing testing execution and summary review as part of the system development life-cycle. Responsible to create, review and sign off laboratory change requests for instruments and routine changes for other systems. Responsible to liaise with laboratory operation subject matter expert and instrument engineers to gather appropriate instrument qualification documents and certification/training documents from the vendor. Responsible to maintain and store documentation in designated documentation management system. Responsible to review, write and implement procedures to enhanced compliance efforts. Develops and maintains competency in spreadsheet validation process. Supports internal and external audit requests for site as needed. Maintains highest standards for LabCorp Drug Development CLS in area of regulatory compliance. Participates in continuing education activities to keep knowledge current. Demonstrates and documents competency as appropriate for regulatory requirements. Maintains a high degree of safety awareness; observes Universal Precautions procedures. Maintains areas/activities in inspection ready condition. Maintains an up-to-date training file. Responsible for assuring that training is received and is documented prior to performing an assignment. Responsible for accuracy of training file and is accountable for any deficiencies found. Demonstrates advanced use and knowledge of computer systems. Provides laboratory management with a monthly report of activities at minimum. Other duties as assigned Labcorp 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.