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QA Associate I, South Africa

QA Associate I, South Africa

Job ID 
11231
Type 
Regular Full-Time
Company 
Hutchinson Centre Research Institute of South Africa
Location 
ZA-Cape Town
Category 
Laboratory Research Sciences

More information about this job

Overview

The HIV Vaccine Trials Network (HVTN) Laboratory Center is part of an international collaboration of scientists and educators searching for effective and safe vaccines. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS and related infectious diseases. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses through to testing vaccine efficacy. The Laboratory Center is responsible for carrying out the scientific agenda of the HVTN by conducting laboratory based studies to evaluate the immunogenicity of investigational vaccines.

 

The Cape Town HVTN Immunology Laboratory (CHIL; www.chil.org.za), a division of the Hutchinson Centre Research Institute of South Africa (HCRISA), performs standardized endpoint assays compliant with GCLP guidelines to analyze immune responses elicited to HIV vaccines in clinical trials.  The laboratory is a state-of-the art facility located in the Gardens neighborhood of central Cape Town.

 

This position will be based in Durban, South Africa

Responsibilities

  • Oversee and support assigned clinical site labs for HVTN and client protocol preparation; includes provision of clinical site training, ensuring appropriate supplies on site, developing and communicating protocol-related lab practices, determining site equipment needs, and monitoring Good Clinical Laboratory Practice compliance.
  • Assist clinical site labs 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.
  • Provide support, investigative consultation, and monitor effective resolution for clinical site laboratory testing, protocol issues and applicable quality system problems.
  • Review and analyze clinical site labs’ workload, performance and adherence to approved Quality Assurance Program.
  • Communicate as needed with Division of AIDS or DAIDs contractors.
  • Provide clinical site lab support, training and protocol lab practice reviews through regular site visits, conference calls or other appropriate media; adapt communication styles based on targeted audience and topic.
  • 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.
  • Manage clinical site supply program including resourcing new supplies and vendors, monitoring site delivery system and oversight of invoices.
  • 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
  • Provide LDMS (centralized laboratory data management system) support to sites; provide program input to the program developer, Frontier Sciences.
  • Provide input and support to HVTN and client protocol teams regarding local lab testing/methodologies, processing, storage and shipping of specimens.
  • Provide input and support to for HIV/AIDS Network Coordination (HANC) lab programs, including the Lab Focus Group.
  • Coordinate, participate and support the efforts of the HVTN Laboratory Program and perform additional activities as necessary.

Qualifications

  • B.S/B.A. required – preferably in a scientific field with Minimum 5 years of experience in clinical safety laboratory.
  • 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 and storage and clinical trials preferred
  • Understanding of HIV diagnostics testing preferred
  • Computer skills – including Microsoft Word, Excel, PowerPoint and other laboratory-specific programs
  • Ability to work in a team
  • Good numeracy, literacy and organizational skills
  • Good interpersonal and time management skills
  • Willingness to be flexible in working hours, be willing to travel as needed (up to 25%), and work some evenings and weekends.

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.