Quality Assurance Officer

**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 logístical 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
- 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 time