Description:
Main purpose of the job:To upgrade and maintain all Quality Assurance and Quality Control processes for the Wits VIDA LaboratoryLocation:Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit, Chris Hani Baragwanath Academic Hospital, Soweto - JohannesburgKey performance areas:Laboratory Quality Assurance and Quality ControlEnsure that the Wits VIDA Laboratory complies with all applicable ISO guidelines, such as but not limited to ISO 9001:2015, ISO 15189:2022 and ISO 17025Perform quarterly internal audits and support external audit/inspection activitiesAssess and identify quality or compliance problems, areas of improvement, and resolving site performancePrepare incident reports for sites to identify bottlenecks and solutions for problemsReport any Quality Control issues to Laboratory ManagementMaintain and monitor the Laboratory Information Management System (LIMS) to ensure that data is adequately captured, saved, reported, and maintainedMaintain and monitor the Laboratory Quality Management System (QMS)Ensure that GCP and GCLP are adhered toAssist with stocktaking and stockroom managementReport and assist in resolving non-conformancesOversee the maintenance and calibration of equipmentWork with clinic staff, lab staff, and sponsor to prepare for auditsMaintain the sterility of the laboratory and all associated areas following the GCLP and ISO guidelines as requiredClinical Trials, Observational Studies, and Fundamental ResearchCollaborating and providing support to Monitors, Clinical Trial Coordinators, Clinic staff, and Laboratory staff to facilitate the smooth running of Clinical Trials at the site levelEvaluate the quality and integrity of study site practices related to the proper conduct of the protocolCreate and review General and Study-specific (SOP)Train relevant staff members on SOPsMaintain Training LogsEnsure that Lab Requisition Forms are checked for errors and filed accordinglyPreparation for site initiation visits, site monitoring visits and study close-out visitsPreparation of Investigator’s Site File (ISF) following GCP and local regulatory requirements and ensuring files are audit-ready. Assist with Trial Master File reconciliationOversee and assist with Data Clarification Forms (DCFs) as well as query resolutionPrepare and file Notes to File (NTFs)Manage logistical shipping process of infectious and Biological substances from the site to the designated trial Sponsor locationManage biohazardous waste and toxic materials removal processesLaboratory Management/AdministrationMonitor and control workflows and turnaround timesCommunicate and discuss incidents with the Laboratory Manager and Senior ScientistWork with management to empower and develop teams or individuals as skills needs or deficiencies are identifiedFoster an environment that promotes talent recognition, development as well as agency and individual leadership; promote harmony, teamwork, and sharing of informationMentor, coach and facilitate personal and
24 Mar 2024;
from:
gumtree.co.za