Medical Technologist (QA)-CC-DE
The NIH is the premier biomedical research center for the world. Its 27 Institutes and Centers employ approximately 18,000 employees doing a vast array of jobs, all supporting efforts for a healthy nation. For information on the NIH mission, goals, and Institutes and Centers, visitNIH Overview
Are you a Medical Technologist with quality assurance and clinical data analysis experience? Do you thrive in a fast-paced environment with concurrent projects and competing deadlines? If so, then consider joining the Cell Processing Section located within the NIH Clinical Center. We are looking for a specialist who will be responsible for the quality oversight of the manufacturing of cellular therapy products in a cGMP facility. In addition to quality assurance experience, interested candidates in this position should demonstrate, in their application package, their experience building custom reports and data visualizations and any experience with information technology systems used in the manufacturing of cellular therapy products (e.g., StemLab, STEMSOFT Lab).
- Not Required
Basic Education Requirements:
A degree in medical technology, chemistry, or biology that included or was supplemented by at least: 16 semester hours of biological science of which one course was in microbiology and one course was in immunology; AND 16 semester hours of chemistry of which one course was in organic or biochemistry; AND 3 semester hours of college mathematics.
A full 4-year course of study that included or was supplemented by at least 12 months in a college or hospital-based medical technology program or medical technology school approved by a recognized accrediting organization. The professional medical technology curriculum may have consisted of a 1-year post-baccalaureate certificate program or the last 1 or 2 years of a 4-year program of study culminating in a bachelor`s in medical technology.
A combination of (1) at least 35 semester hours of biological science, chemistry, and mathematics as described in paragraph A above and (2) additional appropriate education and/or experience totaling 4 years. This combination of education and experience must have provided knowledge of the theories, principles, and practices of medical technology equivalent to that provided by the full 4-year course of study described in A or B above. All science and mathematics courses must have been acceptable for credit toward meeting the requirements for a science major at an accredited college or university. Acceptable experience is: responsible professional or technician experience in a hospital laboratory, health agency, industrial medical laboratory, or pharmaceutical house; or teaching, test development, or medical research program experience that provided an understanding of the methods and techniques applied in performing professional clinical laboratory work. Certification/licensure as a medical technologist (generalist) obtained through written examination by a nationally recognized credentialing agency or State licensing body is a good indication that the quality of experience is acceptable.
You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS- 11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: interpreting and explaining technical requirements such as the regulations and standards of the AABB, The Joint Commission, The Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA), and Occupational Safety and Health Administration standards (OSHA); ensuring a clinical laboratory that manufactures cellular therapy products is in compliance with quality control and quality assurance programs, FDA regulations, Good Manufacturing Practices, and laboratory procedures; drafting standard operating procedures for clinical laboratory personnel on the manufacturing of cellular therapy products; performing manufacturing processes such as cryopreservation, cell separation using counter-flow centrifugation elutriation, immunomagnetic and density gradient techniques for cell separation; analyzing clinical data and preparing data visualizations (Pivot Tables and Charts) using MS Excel; and delivering briefings to senior management and medical professionals on pertinent issues related to the manufacturing of cellular therapy products.
Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education .
Males born after December 31, 1959 must be registered with Selective Service.
Q - Nonsensitive
As a Medical Technologist (Quality), your duties will include, but are not limited to the following:
- Assist with development and implementation of a Quality Systems approach to manufacturing that is compliant with the FDA's Drug Manufacturing inspection compliance program.
- Lead quality improvement processes based on best practices; identifies opportunities for improvement and provides leadership with the initiation and implementation of projects to improve facility processes and meet customer needs.
- Draft quality objectives with specific measurable activities and processes and quality plans as needed for services performed.
- Draft and revise CPS standard operating procedures (SOPs) and pertinent sections of the DTM Facility Drug Master File describing technical methods, procedures, forms, records and quality verification tasks supporting protocol-driven manufacture of cell therapy products.
- Assist with the performance of quality audits performed by external and internal reviewers within the section and department with DTM QA.