Clinical Laboratory Operations QA Associate

4 weeks ago


Cape Town, South Africa Cape Town Immunology Laboratory at Hutchinson Center Research Institute of South Africa Full time

**Position Purpose**:The Quality Assurance Associate is responsible for creating, developing, monitoring and managing quality systems that support ongoing Laboratory Operations of specimen processing for HVTN clinical trials across Southern Africa. A person in this position works on complex problems requiring data analysis and the ability to perform an in-depth evaluation of regulations and policies in selecting methods and techniques for obtaining results. The Quality Assurance Associate has additional responsibilities in leading project efforts and management of quality systems.

**KEY RESPONSIBILITIES**:
**Project Management, coordination, support and implementation (30%)**
- Communicate as needed with Division of AIDS or DAIDS contractors.
- Manage clinical site laboratory supply program including resourcing new supplies and vendors.
- Provide LDMS (centralized laboratory data management system) support to sites; provide program input to the program developer, Frontier Sciences.
- Provide input and support to for HIV/AIDS Network Coordination (HANC) laboratory programs, including the Laboratory Focus Group.
- As needed and working in close collaboration with other HVTN staff, participate in teams that support the implementation of HVTN clinical trials in Southern Africa.
- Other duties and assignments as requested for the overall performance of the department and company.

**Safety Management, Quality control, Quality Assessment Coordination (40%)**
- Oversee and support assigned clinical site laboratories for HVTN and client protocol preparation; includes provision of clinical site training, ensuring appropriate supplies on site, developing and communicating protocol-related laboratory practices, determining site equipment needs, and monitoring Good Clinical Laboratory Practice compliance
- Assist clinical site laboratories with implementation of their tailored Quality Assurance plans, including but not limited to the writing and use of laboratory SOPs, establishment of equipment maintenance programs, and proper data and specimen management.
- Review and analyze clinical site laboratories workload, performance and adherence to approved Quality Assurance Program.
- Provide oversight for Peripheral Blood Mononuclear Cell (PBMC)/serum/plasma processing and cryopreservation training and certification program**.**:

- Provide PBMC External Quality Control (EQC) program support including analysis, interpretation and reporting to sites. Review adequacy of site response on EQC reports.
- Provide input and support to HVTN and client protocol teams regarding local laboratory testing/methodologies, processing, storage and shipping of specimens.

**Clinical Research Support, quality assurance, protocol adherence (30%)**
- Provide clinical site laboratory support, training and protocol laboratory practice reviews through regular site visits, conference calls or other appropriate media; adapt communication styles based on targeted audience and topic.
- Develop and implement clinical site training programs and tools for new specimen processing techniques that include quality assurance practices.
- Work with the Network Specimen Manager to track specimen transport and related quality issues.
- Coordinate, participate and support the efforts of the HVTN Laboratory Program and perform additional activities as necessary.

Other duties, as required.

**EDUCATION, CERTIFICATION, QUALIFICATIONS AND EXPERIENCE NEEDED**:

- B.S./BA/ B-Tech required in a medical scientific field registered with relevant professional body
- At least 5 years of experience as a medical laboratory technologist/ scientist or equivalent
- At least 3 years of experience in quality assurance with understanding of Quality Management Program
- Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance.
- Certified Medical Technologist preferred.
- Experience in clinical safety laboratory management, PBMC (peripheral blood mononuclear cell) processing, sample storage and clinical trial experience.

**COMPETENCIES / JOB SPECIFICATIONS REQUIRED TO DO THE JOB**:

- Understanding of HIV diagnostics testing.
- Demonstrated experience with PBMC (peripheral blood mononuclear cell) processing, sample storage and clinical trials.
- Incident management experience, Laboratory deviations and monitoring corrective and preventative actions.
- Audit and Good Clinical Laboratory Practice (GCLP) experience.
- Good numeracy, literacy, and organizational skills.
- Computer skills - including Microsoft Word, Excel, PowerPoint and other laboratory-specific programs.
- Process improvement and program management skills.
- Flexibility around working hours to accommodate operational needs, be willing to travel (up to 50%) as needed, and work some evenings and weekends
- Ability to think innovatively, manage multiple tasks, and excel under pressure, collaborating with different stakeholders to identify and resolve challenges.
- Ability to take



  • Cape Town, Western Cape, South Africa Cape Town Immunology Laboratory at Hutchinson Center Research Institute of South Africa Full time

    Position Purpose:The Quality Assurance Associate is responsible for creating, developing, monitoring and managing quality systems that support ongoing Laboratory Operations of specimen processing for HVTN clinical trials across Southern Africa. A person in this position works on complex problems requiring data analysis and the ability to perform an in-depth...


  • Cape Town, South Africa Cape Town Immunology Laboratory at Hutchinson Center Research Institute of South Africa Full time

    **Position Purpose**:The Laboratory Operations Manager (LOM) leads the operational team that ensures the physical space, equipment, specimens, and reagents/consumables of the lab efficiently support all lab work. Independent judgment is used in making decisions which affect the current and future success of the lab. The LOM works collaboratively across lab...


  • Cape Town, South Africa IAVI Full time

    **Position Description** **Job Title**:Manager, Clinical Laboratory Operations **Location**: South Africa, or Nairobi Kenya **Reports to**: Associate Director Africa Clinical Lab program **Position Summary**: Are you an experienced Laboratory Professional who is eager to make an impact on global health at an innovative and mission driven organization?...

  • Laboratory Manager

    1 week ago


    Cape Town, South Africa TASK Full time

    **About the Company**: TASK Laboratory is a core team within TASK, a clinical research institute and social enterprise, and is committed to state-of-the-art biological laboratory testing and providing these as a service during the development and progression of novelty medicines, vaccines and diagnostics, in particular the TB therapeutic area. TASK performs...

  • Laboratory Manager

    2 weeks ago


    Cape Town, Western Cape, South Africa TASK Full time

    About the Company:TASK Laboratory is a core team within TASK, a clinical research institute and social enterprise, and is committed to state-of-the-art biological laboratory testing and providing these as a service during the development and progression of novelty medicines, vaccines and diagnostics, in particular the TB therapeutic area. TASK performs...

  • Laboratory Manager

    2 weeks ago


    Cape Town, Western Cape, South Africa Task Applied Science Full time

    Key Performance Areas (KPAs) & Responsibilities include, but not limited to: Ensuring project planning and implementation of all testing according to the trial plan for each study conducted through TASK LaboratoryManaging laboratory budgets and expenditure, ordering of supplies and proactive maintenance of equipment, with consideration of cost/benefit/safety...

  • Scientific Officer

    2 weeks ago


    Cape Town, Western Cape, South Africa Cape Town Immunology Laboratory (Hutchinson Center Research Institute of South Africa) Full time

    Position Purpose:The Scientific Officer (SO) will be responsible for flow cytometry other data analysis for clinical studies. S/he will design experiments, conduct some hands-on research and assist with experimental troubleshooting as required, ensuring that laboratory clinical assays meet appropriate quality level standards. S/he will write laboratory...


  • Cape Town, South Africa TASK Full time

    **Overall Purpose of the Position**: As a Clinical Trial Quality Assurance Manager (QAM), you will play a pivotal role in ensuring the integrity, compliance, and quality of our clinical trials, including when TASK takes on the role and responsibilities of Sponsor in quality oversight and management of a clinical trial on behalf of a sponsor / grant studies....


  • Cape Town, South Africa Synexa Life Sciences Full time

    Join our company that is thriving to improve human health. We're dedicated to creating an innovative and excellent culture that motivates our staff to realize their full potential. We're looking for passionate people who want to make a valuable contribution and who share our vision. Our global company provides a positive and dynamic work environment with...


  • Cape Town, South Africa Novotech Asia Full time

    **Minimum Qualifications & Experience** Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical...


  • Cape Town, Western Cape, South Africa Novotech Asia Full time

    Minimum Qualifications & ExperienceGraduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.Preferably experience of working in the research, pharmaceutical...

  • QA / Ra Associate

    2 weeks ago


    Cape Town, Western Cape, South Africa Zeal HR Full time

    An excellent opportunity has become available within the medical device industry, for a QA / RA Associate based in Cape Town.Responsibilities: Assist in obtaining and maintaining approvals for the medical devices at the Company by ensuring regulatory requirements are known and met within the company Directs or performs coordination and preparation of...


  • Cape Town, South Africa TASK Full time

    **About the Company**: TASK Laboratory is a core team within TASK, a clinical research institute and social enterprise, committed to state-of-the-art biological laboratory testing and providing these as a service during the development and progression of novelty medicines, vaccines and diagnostics, in particular the TB therapeutic area. TASK performs...


  • Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:As a Clinical Trial Quality Assurance Manager (QAM), you will play a pivotal role in ensuring the integrity, compliance, and quality of our clinical trials, including when TASK takes on the role and responsibilities of Sponsor in quality oversight and management of a clinical trial on behalf of a sponsor / grant studies. You...


  • Cape Town, Western Cape, South Africa Synexa Life Sciences Full time

    Join our company that is thriving to improve human health. We're dedicated to creating an innovative and excellent culture that motivates our staff to realize their full potential. We're looking for passionate people who want to make a valuable contribution and who share our vision. Our global company provides a positive and dynamic work environment with...


  • Cape Town, South Africa TASK Full time

    **Overall Purpose of the Position**: To ensure the delivery of high-quality clinical tuberculosis laboratory services, the Laboratory Information Officer provides crucial support to the laboratory through accurate reporting, proficient data management, and administrative duties within the framework of TASK Laboratory's activities for clinical drug trials and...


  • Cape Town, South Africa Hutchinson Center Research Institute of South Africa Full time

    **Responsibilities**: **Management and Training of the Endpoints Lab Team (30%)** - Supervise a team of laboratory technologists performing assays for clinical trials and research purposes, including assays such as multiparameter flow cytometry, multiplex protein detection and molecular assays. - Develop and maintain a relevant and dynamic training program,...

  • Laboratory Technician

    3 weeks ago


    Cape Town, South Africa Synexa Life Sciences Full time

    **Job Purpose**: **Main areas of responsibility**: - Performs routine clinical sample analysis as per in-house standard operating procedures (SOP´s) and validated protocols under the guidance of Scientists. - Ensures clear audit trails by performing quality control of all information and data generated. - Reporting data generated and assisting in the...


  • Cape Town, South Africa TASK Full time

    **Laboratory Medical Technician** **About the Company**: TASK is a South African headquartered, multinational clinical research institute that conducts clinical trials to determine the treatment effects of novel medicinal products or devices in healthcare and offers services in conducting complex clinical trials in a wide variety of therapeutic areas. TASK...

  • Laboratory Supervisor

    2 weeks ago


    Cape Town, Western Cape, South Africa TASK Full time

    Overall Purpose of the Position:To provide first class clinical tuberculosis laboratory services by performing technical procedures and administrative duties, as well as to oversee tasks delegated to laboratory staff, within the scope of activities provided by the TASK laboratory for clinical drug trials.Key Performance Areas (KPAs) & Responsibilities...