Laboratory Quality Assurance Manager (WRAIR-Malaria Serology Laboratory)
GDIT is seeking a laboratory quality assurance manager to support WRAIR's Malaria Serology Lab. The contractor shall ensure that high quality standards are met. Specifically, the contractor shall:
- Work to sustain a high degree of assay consistency and reproducibility of data by checking all data integrity, developing formal SOPs and ensuring adherence to GCLP standards and Federal guidelines;Monitor training requirements of all MSL staff and develop validation and qualification plans for assays;Assist in assay development; andTroubleshoot and further expand laboratory capabilities. This includes but is not limited to: ELISA, Softmax Pro GXP Avidity, IFA, Luminex, and Biosensor technology.The contractor shall be cross trained in optimizing and operating multiple specialized assay platforms to include ELISA, IFA, Luminex, and biosensor technology. The contractor shall have the broad knowledge base of malaria and immunochemistry in order to troubleshoot and further expand laboratory capabilities. The contractor shall be qualified to perform multiple assay platforms and ensure high sample throughput to maintain the Malaria Serology Laboratory’s capacity to perform the high volume of sample analysis required to meet the demands of the USMMVP, MMRP, and the MSL’s non-DoD funders (USAID and PATH-MVI)The contractor shall work directly with the lab PI (Chief, Clinical Immunoparasitology, and MVB) to develop novel assays using alternate technologies ensuring the MSL maintains and cultivates cutting edge technologies to increase lab visibility worldwide, fostering new funding opportunities and scientific partnerships.The contractor shall routinely produce scientific papers, journal articles, assay validation reports and other scientific outcome reports. The contractor shall have a detailed knowledge of malaria immunology and, in particular, the host humoral immune response and host-parasite immune interactions.
- 8-10 years of related quality assurance experience, including supervisory experience.
- Knowledge of method validation, statistical analysis, and laboratory audits and accreditation.
- Proficiency with molecular, biochemical, parasitological and immunological assays development and optimization, biostatistical analysis methods.
- GCLP, GLP, Microscopy and Data management certifications desired
- Familiarity with Softmax Pro/GxP, Spectramax, BioTek ELx405 and LS, Data management and quality control/assurance.