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Quality Assurance Specialist

JOB TITLE: Quality Assurance Specialist
POSITION NUMBER: 1811-92743-QAS-011
ANTICIPATED START DATE: Two weeks after candidate identification
TRAVEL: As required to fulfill the responsibilities of the position
IHRC, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to the Centers for Disease Control and Prevention (CDC) and other Federal and private sector clients. The successful candidate will be a full-time employee of IHRC, Inc., and will be assigned to the Laboratory Preparedness and Response Branch (LPRB), Division of Preparedness and Emerging Infections (DPEI), National Center for Emerging and Zoonotic and Infectious Diseases (NCEZID), at the CDC, 1600 Clifton Road, Atlanta, GA. The selected candidate will provide quality assurance support for the development and deployment of quality assays and products to LRN member laboratories, the continuous monitoring and improvement of the branch quality management system, and the enhancement of existing and next generation assay development research activities, and the public health capacity of the LPRB.
The mission of the LPRB is to develop and validate new technologies for rapid identification of unknown samples, to provide rapid assays to the Laboratory Response Network (LRN), and to support the LRN with technical expertise in all assays deployed to the LRN through:
  • Developing, evaluating, and validating rapid methods for identification of bacterial agents using advanced technologies
  • Developing extraction methods for various sample types to facilitate rapid identification of bacterial agents in environmental and clinical samples
  • Providing training and consultation on technical issues associated with LRN protocols
  • Overseeing the development and deployment of new methods and technologies by the LRN technical review committee (TRC)
  • Establishing procedures for Performance, Production, Quality Assurance (QA) and Quality Control (QC) for LRN reagents
  • Working with federal agencies such as FBI, DHS, DoD, and EPA to coordinate response procedures
Within LPRB is the Product Development Team, which develops assays and works closely with CDC subject matter experts (SMEs) to support the LRN with research and development of new methods. The Product Development Team provides real-time PCR testing for bacterial and viral agents, and collaborates with CDC SMEs, as well as LRN labs in developing, evaluating, and validating novel rapid methods for pathogen identification. The team facilitates the review of all assay data and documentation through the Technical Review Committee (TRC), a requirement for All LRN Assays.
The Quality Assurance Specialist will support the development of quality diagnostic assays that utilize technology including but not limited to real-time PCR and ELISA, and their deployment to LRN member laboratories.
  • Develop study plans and complete risk assessments in accordance with branch policies, and Clinical and Laboratory Standards Institute (CLSI) guidelines where applicable
  • Collaborate with assay developers on the transfer, development and implementation of procedures and documentation needed for the assay (e.g., product documentation, analytical method transfer describing method specifications, validation, and in-process QC)
  • Collaborate with assay developers to determine and draft required product specifications and review materials and supplies to ensure product specifications, inserts and labels contain detailed and required information that support the assay
  • Collaborate with cross-functional teams (e.g. subject matter experts, product development, statisticians, quality management) to understand assay technology
  • Provide administrative oversight of feedback, complaints, non-conforming events and Corrective Action Preventive Action (CAPA) and/or document control systems to ensure compliance to established procedures
  • Work with LPRB Quality Team Lead to ensure compliance to the requirements of the branch wide training program
  • Generate statistical tracking and trending reports on a regular basis to monitor compliance to established quality system requirements
  • Interpret tracking and trending data and identify potential areas of improvement
  • Create narratives to support labeling claims, including interpretation and organization of experimental data that support device labeling claims
  • Investigate and resolve discrepancies within experimental data
Education and Experience:
  • Degree in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, or other field related to the position
  • Bachelor’s with 7-15 years of experience in a similar role
  • Master’s with 5-10 years of experience on a similar role
  • Ph.D. with 0-5 years of experience in a similar role
  • Extensive experience reviewing production activities and capabilities in light of contract quality requirements
  • Extensive experience reviewing written quality or inspection procedures for adequacy, and evaluating the implementation and effectiveness of quality/inspection systems, including sampling plans.
  • Extensive experience analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system
  • Extensive experience verifying by test or inspection, using sampling inspection or intensive product inspection techniques, that products comply with requirements prior to acceptance
  • Extensive experience identifying inadequacies and requesting corrective action
  • Extensive experience computing data, summarizing results, and preparing reports or charts depicting pertinent relationships using statistical methods
  • Extensive experience investigating customer complaints and deficiency reports, and providing identification of causes to appropriate authorities
  • Extensive experience reading, interpreting, and applying technical data such as blueprints, engineering drawings, product specifications, or technical manuals
  • Extensive experience reviewing and evaluating supply systems operations and procedures through periodic audits and surveillance inspections
  • Extensive experience developing and executing experimental plans, creating test cases, test data, matrices and other QA related documents
  • Extensive experience designing and testing strategies for the analysis and certification of products
  • Extensive experience reviewing change requests (CCR) for completeness
  • Extensive experience developing novel approaches to solve problems identified during quality assurance activities
  • Extensive experience working within a multidisciplinary scientific environment
  • Extensive experience ensuring compliance with all contract and task order requirements and quality standards
  • Knowledge of biosafety requirements for research being performed
  • Strong interpersonal skills and extensive experience interacting with internal and external partners
  • Experience working with Visio and Microsoft Office; including, Word, Access, Excel, and PowerPoint
  • Experience working with Pilgrim SmartSolve eQMS software
  • Research experience involving real-time PCR, ELISA, and other technologies
  • Demonstrated skills and experience writing project reports, research protocols and manuscripts
  • Extensive knowledge and experience with the research activities involved with in vitro assay development, the ability to provide technical guidance to scientific personnel performing assay development research, and the ability to provide quality review of project deliverables
  • Demonstrated ability to meet or exceed project deliverables and timelines 
  • Demonstrated ability to synthesize new ideas for project research
  • Demonstrated experience using statistical software such as SAS, or SPSS to analyze assay data
  • Demonstrated experience developing real-time PCR, ELISA, or next-generation sequencing in vitro diagnostic assays
Language Skills:
  • The candidate must possess excellent oral and written communication skills in English 
  • Must be United States citizen or permanent resident or have authorization for employment in the United States
SALARY: Commensurate with qualifications and experience
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IHRC, INC. IS AN EQUAL OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER. It is the policy of IHRC, Inc. to provide equal employment opportunities without regard to race, color, religion, citizenship, age, sex, sexual orientation, gender identity, national origin, ancestry, genetic information, veteran or disability status, or any other characteristic protected by applicable federal, state or local law, and to take affirmative action in accordance with applicable laws and Executive Orders.