Cincinnati Metropolitan Area
Data Reviewer with 8+ years of experience in the pharmaceutical industry across various roles. Demonstrated familiarity with departmental SOPs and regulatory requirements. Facilitated workflows to meet deadlines within the department. Corresponded with cross-departmental personnel to achieve client-based goals.
Data Reviewer at a cGMP pharmaceutical Contract Manufacturing Org (CMO) in the Quality Control Laboratory • Communicated with laboratory personnel to address quality concerns • Reviewed laboratory generated documentation and test results for compliance with site SOPs and client product method requirements • Released deliverables in accordance with client shipping timelines. • Addressed deviant test results with departmental personnel to meet client project requirements
Held multiple roles in the cGLP Bioanalytical Laboratory at a pharmaceutical Contract Research Organization (CRO) • Addressed quality concerns with laboratory personnel • Reviewed laboratory generated documentation and test results for compliance with site SOPs and client protocol requirements • Prepared study related materials for client and regulatory audit readiness • Responded to client requests for investigations into deviant results to meet requisite regulatory requirements • Reviewed study reports for compliance with protocol requirements to meet client timelines for study regulatory closeout
• Generated compliant laboratory documentation • Performed data analysis • Coordinated with clients to maintain study sample chain of custody • Consulted with cross-departmental personnel to troubleshoot client specifications for data integrity
Biological Research Assistant in the Gastroenterology research laboratory. • Supported on-going research projects • Conducted data analysis • Collected and analyzed biological samples
Performed routine laboratory testing in the quality control lab. Collected and reported data for on-site manufactured aerospace products.