Quality Assurance Specialist (BS/MS) (Molecular Diagnostics) with Security Clearance

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Job description

Position Summary Odyssey is looking for a Quality Assurance Manager to support the Molecular Diagnostics Department in the Biological Defense Research Directorate (BDRD) at the Naval Medical Research Center (NMRC). The goal of this group is to broaden the ability of the Directorate to produce quality assays and reagents for the detection of bio-threat agents domestically and across the globe. The mission of the Microbiology and Immunology (MI) and Molecular Diagnostic (MD) departments of Naval Medical Research Command BDRD is to research, develop and produce detection and mitigation products to counter biological threat agents, both natural and man-made domestically and across the globe. Contingent upon contract award Responsibilities Duties include, but are not limited to: Production of Real-Time Polymerase Chain Reaction Assays (support to MD Department): The contractor shall assist with production of reagents for daily use by DoD and Federal programs to detect the presence of biological warfare agents in multiple different sample types and for ongoing disease surveillance across the globe. Reagent production is conducted under ISO 17034 and17025 standards in an accredited laboratory to produce testing material and produce certified reference materials. To meet these production standards, a rigorous Quality Management System is in place that governs the production of all assay components. To support this project, assistance with the following tasks shall be performed: Produce nucleic acid-based detection/diagnostic assays against various biological threat agents; Conformance test detection/diagnostics assays to ensure performance meets stated standards; Continually improve Quality Management System to meet applicable accreditation standards; and Maintain repository of assay kits and ship (subject to prior Government approval) to DoD and United States Government (USG) customers CONUS and OCONUS. Molecular Assay Development & Platform Test and Evaluation (support to MD Department): The contractor shall assist with the development and testing of new or improved nucleic acid-based detection assays to meet the needs of DoD and other Federal agencies. The contractor shall transition these assays into production based on customer needs. The contractor shall assist with assay development that may include platform test and evaluation to compare performance of new or improved platforms or components with currently fielded platforms. Laboratory support will include work in BSL-2 and BSL-3 laboratories with BSAT requiring enrollment in a BPRP. To support this project, assistance with the following tasks shall be performed: Develop DNA or RNA detection assays with the goal of improving currently fielded assays and/or increasing U.S. Government (USG) assay portfolio; Develop DNA or RNA detection/diagnostic assays in response to public health emergencies. Assays may require specific validation packages to obtain FDA Emergency Use Authorization or other necessary approval/certification; and Conduct assay and platform test & evaluation of new or improved nucleic acid based instruments and technologies to identify potential improvements in USG detection/diagnostic capabilities. Provide and evaluate proficiency testing (PT) for biological threats (support to MD Department): The contractor shall assist with the production, packaging, shipment of proficiency testing materials to DoD laboratories throughout the U.S. and worldwide. The program serves to assess the readiness of the DoD biological warfare (BW) agent detection laboratories. Customers include the U.S. Navy Surface Fleet assets, Navy and Marine Corps Force Health Protection Command, Military Sea Lift Command (MSC), and USAF. Produce and quality test lyophilized or frozen PT to be shipped to each participating sites with the intent of identifying the lab competencies required. Produce, test and evaluate expanded food and water (F&W) matrices to existing air and surface swab testing events. Perform mission-specific training off-site (travel required) or at NMRC-Fort Detrick, Maryland as requested. Field Sample Analysis (support to MD, MI and ELOD Departments): The contractor shall assist with maintaining a capability for analysis of unknown samples to identify suspected biological threat agents. This project includes support to the CDC as a National Laboratory in the Laboratory Response Network (LRN) and support to DoD and other federal customers in unknown sample analysis. The contractor shall provide laboratory support that will include at a minimum, standard microbiological analysis, nucleic acid analysis, and immunological analysis and will include work in Biosafety Level (BSL)-2 and BSL-3 laboratories with BSAT requiring enrollment in a BPRP. The contractor shall provide laboratory support of off-site analysis conducted in field settings or in partner laboratories. To support this project, assistance with the following tasks shall be performed: Conduct unknown sample analysis and proficiency testing as requested and required by the CDC Laboratory Response Network; Conduct on-site and off-site analysis for NMRC (in support the Department of Homeland Security and other Federal entities); Conduct analysis for NMRC and the Department of Defense (CONUS & OCONUS); Conduct unknown sample analysis for Federal law enforcement agencies; and Conduct training and exercises in field sample analysis for DoD and other Federal entities. Contingent upon contract award Qualifications Minimum Required Qualifications Citizenship: Must be a US citizen Clearance: Secret (Able to Obtain) Education: Bachelor's or Master's degree, or equivalent experience in a biological science field and quality management. Years of Experience: 5 years of practical experience in molecular biology and quality management is considered essential. Skills: The candidate must have demonstrated the ability to independently operate and exercise an ISO accredited laboratory quality system, to include writing standard operating procedures and reports, conducting training, reviewing data, interfacing with outside accrediting bodies in preparation of annual audits and conducting internal audits, assist production manager in all aspects of daily operations, continually upgrade and improve production database records, and devise budgets. Candidate should be well versed in the use of Filemaker database. The candidate should have at least 5 years of experience in the field of quality management in an ISO 17034/17025 accredited reagent production laboratory.
• Must currently possess or be able to pass all criteria for a Secret security clearance. Contractor personnel must be able to travel nationally and internationally for moderate periods of time (up to 2 weeks in length). Additional Information Location: Frederick, MD Travel: up to 20% Remote, Onsite, or Hybrid: Onsite Contingent upon contract award Company Overview Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Please Note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications. Salary range available upon request.

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