Clinical Laboratory Operations QA Associate

2 days 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

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