Summary This position serves as the Chief of the Quality Assurance Unit in the Department of Transfusion Medicine. The Quality Unit within the BE is responsible for ensuring the safety, quality, purity, potency, and effectiveness of all services and activities in the BE and for ensuring the reliability of services and data is in accordance with accrediting and regulatory agency requirements including NIH, FDA, CMS, AABB, ASHI, and TJC. Responsibilities The incumbent serves as the Chief of the Quality Assurance Unit. To carry out this responsibility, the incumbent performs the following duties and responsibilities: Assesses, develops, implements, and manages the Unit's programs, policies and services and assures they are consistent with DTM organizational goals, priorities and practices. Formulates and carries out program plans. Analyzes new and emerging issues while developing strategies and solutions to respond to these in the form of new procedures and methods. Ensures the program is administered in accordance with pertinent regulations, policies and procedures. Evaluates staff and organizational effectiveness in accomplishing assigned goals and tasks and trouble-shoots problems that arise in accomplishing the goals and objectives of the Unit. Oversees the development and implementation of more efficient and streamlined methods and procedures to accomplish the goals and objectives of the Unit. Collaborates with appropriate NIH departments to ensure that the programs and activities meet the needs of the Clinical Center and NIH. Requirements Conditions of Employment Qualifications Basic Requirements: Education Bachelor's or graduate/higher level degree from a regionally accredited college/university including courses in biological science, chemistry and mathematics, AND successful completion of a Medical Laboratory Scientist/Clinical Laboratory Scientist program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. OR A full 4-year course of study that included 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 bachelor's certificate program or the last 1 or 2 years of a 4-year program of study culminating in a bachelor's in medical technology. OR A Bachelor's or graduate/higher level degree from an accredited college/university, including 16 semester hours (24 quarter hours) of biological science (with one semester in microbiology), 16 semester hours (24 quarter hours) of chemistry (with one semester in organic or biochemistry), one semester (one quarter) of mathematics, AND five years of full time acceptable clinical laboratory experience in Blood Banking, Chemistry, Hematology, microbiology, Immunology and Urinalysis/Body Fluids. 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. ADDITIONAL REQUIREMENT: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-13 level in the Federal service obtained in either the private or public sector performing the following types of tasks: providing guidance and direction to quality assurance staff; establishing and monitoring quality management programs in FDA-registered Blood Establishments (BE); ensuring regulatory compliance of relevant blood banking regulations, policies, and procedures (e.g. FDA cGMP, cGTP, AABB accreditation standards, ASHI); and administering the program accordingly; developing strategies and solutions for blood banking related process improvements; and implementing methods and procedures to achieve a blood banking program's organizational goals and objectives. Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12561998 Education 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. Additional Information This position is designated as a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave. If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency. This information is required annually. For information, visit the NIH Ethics website: https://ethics.od.nih.gov/fd. At the supervisor's discretion, this position may offer work schedule flexibilities: [telework (work from home on a regular basis or ad hoc basis but reports to the office at least once a week/two days a pay period), compressed schedules, flexible schedules]. A one-year Supervisory trail/ probationary period may be required upon selection/placement. PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration. Veterans' Preference applies only to Schedule A (disability appointment) and Veterans Recruitment Appointments (if applicable). The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers. The NIH maintains a tobacco free work environment and campus. Must be able to perform the essential duties of the position, with or without reasonable accommodation. Visit our Applicant FAQs page for helpful information on the application process. Visit our Total Compensation page and this sample for a detailed look into the benefits, awards, leave, retirement, and other incentives employees may receive as part of a rewarding work environment.