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 professional staff developmentEnsure teams comply with policies, unit standards, and administrative and internal communications requirements; promote company policies, strategies, and valuesManage staff effectively including accountability, performance, conduct, efficient working, processes, and corrective action on sub-standard performance and issues, as requiredDemonstrate effective delegation and decision-making (apply considered discretion and professional insight)Support and drive effective resource management including short- and long-term staffing requirements, optimal staff utilization, and maintaining sound labor relationsEffective Self-management and Performance OwnershipTake ownership and accountability for tasks and demonstrate effective self-managementFollow through to ensure that quality and productivity standards of own work are consistently and accurately maintainedTake responsibility for timekeepingMaintain a positive attitude and respond openly to feedbackTake ownership of driving own career development by participating in ongoing training and development activitiesYou may be required to perform other duties and responsibilities within your abilities at the request of your Line Manager as per the WHC terms and conditions of employmentRequired minimum education and training:MSc Degree in a Science or related fieldMust have OHS/SHEQ CertificationRequired minimum work experience:Minimum 5 years of experience in an Infectious Disease Research Laboratory, Medical Microbiology, Immunology or Clinical Pathology LaboratoryMust have QC/QA experienceDesirable additional education, work experience, and personal abilities:Laboratory experience and knowledge of GCP, GCLP, IATA, and ISO guidelines must be adhered to at all timesExposure to hazardous and potentially infectious samplesWork in a pressurized environment in meeting turnaround times in high volumesYou may be required to perform other duties and responsibilities within your abilities at the request of your line manager as per the WHC terms and conditions of employmentTO APPLY:Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.Please Apply Online.Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.The closing date for all applications: 10 May 2024.Note AJ Personnel is fully POPI compliant.Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.Please note:AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.Wits Health Consortium will only respond to shortlisted candidates. Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.AJ Personnel does not have any salary or other information regarding the position.