Quality Assurance Officer (Laboratory) Wits VIDA - - Soweto

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:

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: 02 April 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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