The Quality Unit within The Department of Transfusion Medicine is responsible for ensuring the safety, quality, purity, potency and effectiveness of all services and activities in DTM 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 Quality Assurance Specialist is responsible for the administration of the Quality Assessment/Improvement (QA/I) program within DTM.

Duties

As a GS-1910-12 Quality Assurance Specialist your duties may include but are not limited to the following: Assisting with the development and implementation of a Quality Systems approach to manufacturing that is compliant with the FDA's Drug Manufacturing Inspection Compliance Program which includes the Quality System and 5 manufacturing systems: Production System, Facilities and Equipment System, Laboratory Controls System, Materials System, Packaging and Labeling System and Quality System. Implements and monitors the CCE and DTM quality management program that promotes process excellence and is based on the Quality System Essentials (QSE) approach. Leading quality improvement processes based on best practices; identifying opportunities for improvement and providing leadership with the initiation and implementation of projects to improve facility processes and meet customer needs. Reviewing and identifying compliance gaps for revised FDA cGMP and cGTP guidelines and communications for changes to federal regulations and current guidance for compliance for blood product manufacturing about, but not limited to, blood product manufacturing including donor eligibility and testing for transmissible disease, human cells and tissues, donor eligibility determination and testing human cells and tissues for transmissible disease. Reviewing and identifying compliance gaps for compliance with new or modified AABB accreditation standards and NIH -CC and DTM policies and procedures for blood product manufacturing and human cells and tissues collections that include testing for risk of transmission of communicable disease. Drafting quality objectives with specific measurable activities and processes and quality assurance plans, as needed, for services performed.

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.
• The work requires regular and recurring physical exertion such as long periods of standing and walking, bending over instruments and microscopes, and lifting light to moderately heavy items such as reagents packs and various supplies.
• If selected, you must pass a pre-employment medical examination.
• Work environment involves regular and recurring exposure to infectious agents such as hepatitis and HIV and to noxious and flammable liquids such as xylene and formalin. Required to use protective clothing and this is a Biohazard Level 2 facility.
• This position is designated as a Tier II emergency employee.
• Able to lift/carry 15 pounds.

Qualifications

You qualify at the GS-12 level if you meet the following qualification requirements: One year of specialized experience equivalent to at least the GS-11 grade level in the Federal service obtained in either the private or public sector performing the following types of tasks: Administering a Cellular Therapy Quality Assurance(QA)/Inspection program including process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency; Assuring manufacturing and testing of cellular therapy products processes are in compliance with FDA cGMP and cGTP guidelines and communications for Cellular and Gene Therapies, Phase I/II Investigational Drugs and Human Cells, Tissues, and Cellular and Tissue Based Products, standards of the American Association for the Advancement of Blood and Biotherapies; drafting and revising standard operating procedures describing technical methods, procedures, forms, records and quality verification tasks supporting protocol-driven manufacture of cell therapy products; and assisting with the performance of quality audits performed by external and internal reviewers and reviewing audit finding, 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12439575

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]