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Summary 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 responsible for the administration of the Quality Assessment/Improvement (QA/I) program of the CCE. Responsibilities 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. Administering the QA/I program in the CCE, including process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency. Reviewing 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 AABB, and current NIH CC and DTM policies and procedures to assure manufacturing and testing of cellular therapy products processes are in compliance. Ensuring there are mechanisms to monitor processes/systems that are considered to be critical to workplace safety; infection control; and safety and quality of the final products manufactured within a cGMP facility. Requirements Conditions of Employment Qualifications In order to quality for a Quality Assurance Specialist, 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 Government obtained in either the private or public sector, performing the following types of tasks: Performing Quality Assurance (QA)/Inspection for an aseptic processing and/or cGMP facility that include 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 and reviewing audit finding, following up with any necessary corrective and preventive actions and preparing responses as needed. 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: https://apply.usastaffing.gov/ViewQuestionnaire/12511424 Education Additional Information This position is designated as an "emergency essential" position and the selected candidate will be considered an "emergency essential" employee and will be required to be available, ready, willing, and able to report for duty under all circumstances (e.g., inclement weather, government closings and holidays, lapses in appropriations, non-emergency, and emergency situations) for operation 24 hours a day and 365 days per year coverage. A one-year 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 We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions. 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. 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