The Quality Unit within the CCE is responsible for ensuring the safety, quality, purity, potency, and effectiveness of all services and activities in the CCE and for ensuring the reliability of services and data is in accordance with accrediting and regulatory agency requirements including NIH, USP, FDA, and TJC. The incumbent serves as a Quality Assurance Specialist (Hematopoietic) responsible for the Quality Assessment/Improvement (QA/I) program for hematopoietic stem cells in the CCE.

Duties

As a GS-1910-12 Quality Assurance Specialist (Hematopoietic Stem Cell Therapy), your duties may include but are not limited to the following: Administering the hematopoietic stem cell quality program in the CCE including process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency. Ensuring that CCE activities are in compliance with AABB (Association for the Advancement of Blood and Biotherapies), Federal Drug Administration (FDA), and other standards related to the processing, storage, and infusion of hematopoietic stem cells. Serving as the primary CCE point of contact for accreditation applications and inspections with the AABB, other accrediting organizations or entities for off-site manufacturing protocols. Coordinating activities related to inspections and audits of the CCE by the AABB, other accrediting organizations, or entities for off-site manufacturing protocols. Ensuring patient reactions related directly to the infusion of hematopoietic stem cell products, cell therapies, and gene therapies are appropriately documented and appropriately reported.

Requirements

• 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 the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
• If selected you must pass a pre-employment medical examination.
• The work requires regular and recurring physical exertion such as long periods of standing and walking and lifting light to moderately heavy.
• Required to use protective clothing and work is performed in a Biohazard Level 2 facility.
• This position is a Tier 1 Emergency Essential position.

Qualifications

In order to qualify for a Quality Assurance Specialist (Hematopoietic Stem Cell Therapy), GS-1910 position at the GS-12 level, you must have: One 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: Administering a Hematopoietic Stem Cell Therapy Quality Assurance program including process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency; Ensuring activities are in compliance with AABB, FDA and other standards related to the processing, storage, and infusion of hematopoietic stem cells; drafting and revising standard operating procedures; describing technical methods, procedures, forms, records and quality verification tasks; assisting with the performance of quality audits performed by external and internal reviewers and reviewing audit findings, following up with any necessary corrective and preventive actions and preparing responses as needed. 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. IPreview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12378203

Education

This job does not have an education qualification requirement.

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: NIH HR Service Desk Branch E
• Email: [email protected]