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.

Duties

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; and
• 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

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Position requires Education, please submit transcripts.
• A one-year supervisory trial/probationary period may be required upon selection/placement.
• If selected, you must pass a pre-employment medical examination.
• Occasional travel maybe required.
• Tier II position.

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.

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.

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.

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:

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

You will be assessed on the following competencies (knowledge, skills, abilities, and other characteristics):

• 1. Ability to establish and monitor quality management programs in FDA-registered Blood Establishments (BE).
• 2. Ability to ensure regulatory compliance through thorough understanding of relevant regulations, policies, and procedures (e.g., FDA cGMP, cGTP, AABB accreditation standards, ASHI) and administering the program accordingly.
• 3. Ability to supervise a quality assurance staff within a blood banking facility.
• 4. Ability to develop strategies and solutions for processing improvements for blood banking program.

If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:

• Best Qualified - for those who are superior in the evaluation criteria
• Well Qualified - for those who excel in the evaluation criteria
• Qualified - for those who only meet the minimum qualification requirements

The Category Rating Process does not add veterans' preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.

To be considered well qualified for the purposes of the and the , you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least an 85 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.
Candidates are encouraged to submit a diversity statement describing their commitment to promoting diversity, equity, inclusion, and accessibility (DEIA) as evident in a track record of activities within their resume/cover letter. If invited for an interview you will be required to display your commitment to promoting diversity and inclusion such as, but not limited to, mentoring individuals from underrepresented groups, participating in mentoring programs designed to promote diversity, and DEIA related outreach activities."

Required Documents

REQUIRED FOR ALL APPLICANTS
RESUME:
Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.

To ensure all of the essential information is in your resume, we encourage you to use the . If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

1. Job title
2. Name of employer
3. Beginning and ending dates of employment (month/day/year format)
4. Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
5. Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
6. Series and grade or equivalent (if a federal position)

If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.

Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.

For resume writing guidance, please visit the following resources: , , and the .

ASSESSMENT QUESTIONNAIRE:
You must submit a completed assessment questionnaire.

Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.

REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS
To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.

• (DD-214, VA Disability Letter, etc.): Reference for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the is submitted with your application package.
• Visit our sites on / for more information and required documentation.
• Visit our site on the for more information and required documentation to verify eligibility.
• Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.

The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.

If you do not provide the required information, we will assume you are not eligible, or you do not wish to be considered for any preference or eligibility.

Do not submit documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

PDN-9d7fec16-0339-45f4-9154-e11e0548b074