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    Quality Assurance Officer - Soweto, South Africa - AJ Personnel

    AJ Personnel
    AJ Personnel Soweto, South Africa

    6 days ago

    AJ Personnel background
    Description

    Main purpose of the job:

    • To upgrade and maintain all Quality Assurance and Quality Control processes for the Wits VIDA Laboratory

    Location:

    • Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit, Chris Hani Baragwanath Academic Hospital, Soweto - Johannesburg

    Key performance areas:

    Laboratory Quality Assurance and Quality Control

    • Ensure 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 17025
    • Perform quarterly internal audits and support external audit/inspection activities
    • Assess and identify quality or compliance problems, areas of improvement, and resolving site performance
    • Prepare incident reports for sites to identify bottlenecks and solutions for problems
    • Report any Quality Control issues to Laboratory Management
    • Maintain and monitor the Laboratory Information Management System (LIMS) to ensure that data is adequately captured, saved, reported, and maintained
    • Maintain and monitor the Laboratory Quality Management System (QMS)
    • Ensure that GCP and GCLP are adhered to
    • Assist with stocktaking and stockroom management
    • Report and assist in resolving non-conformances
    • Oversee the maintenance and calibration of equipment
    • Work with clinic staff, lab staff, and sponsor to prepare for audits
    • Maintain the sterility of the laboratory and all associated areas following the GCLP and ISO guidelines as required

    Clinical Trials, Observational Studies, and Fundamental Research

    • Collaborating and providing support to Monitors, Clinical Trial Coordinators, Clinic staff, and Laboratory staff to facilitate the smooth running of Clinical Trials at the site level
    • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol
    • Create and review General and Study-specific (SOP)
    • Train relevant staff members on SOPs
    • Maintain Training Logs
    • Ensure that Lab Requisition Forms are checked for errors and filed accordingly
    • Preparation for site initiation visits, site monitoring visits and study close-out visits
    • Preparation of Investigator's Site File (ISF) following GCP and local regulatory requirements and ensuring files are audit-ready. Assist with Trial Master File reconciliation
    • Oversee and assist with Data Clarification Forms (DCFs) as well as query resolution
    • Prepare and file Notes to File (NTFs)
    • Manage logistical shipping process of infectious and Biological substances from the site to the designated trial Sponsor location
    • Manage biohazardous waste and toxic materials removal processes

    Laboratory Management/Administration

    • Monitor and control workflows and turnaround times
    • Communicate and discuss incidents with the Laboratory Manager and Senior Scientist
    • Work with management to empower and develop teams or individuals as skills needs or deficiencies are identified
    • Foster an environment that promotes talent recognition, development as well as agency and individual leadership; promote harmony, teamwork, and sharing of information
    • Mentor, coach and facilitate personal and professional staff development
    • Ensure teams comply with policies, unit standards, and administrative and internal communications requirements; promote company policies, strategies, and values
    • Manage staff effectively including accountability, performance, conduct, efficient working, processes, and corrective action on sub-standard performance and issues, as required
    • Demonstrate 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 relations

    Effective Self-management and Performance Ownership

    • Take ownership and accountability for tasks and demonstrate effective self-management
    • Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
    • Take responsibility for timekeeping
    • Maintain a positive attitude and respond openly to feedback
    • Take ownership of driving own career development by participating in ongoing training and development activities
    • You 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 employment

    Required minimum education and training:

    • MSc Degree in a Science or related field
    • Must have OHS/SHEQ Certification

    Required minimum work experience:

    • Minimum 5 years of experience in an Infectious Disease Research Laboratory, Medical Microbiology, Immunology or Clinical Pathology Laboratory
    • Must have QC/QA experience

    Desirable additional education, work experience, and personal abilities:

    • Laboratory experience and knowledge of GCP, GCLP, IATA, and ISO guidelines must be adhered to at all times
    • Exposure to hazardous and potentially infectious samples
    • Work in a pressurized environment in meeting turnaround times in high volumes
    • You 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 employment

    TO 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.
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