Quality Assurance Specialist

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: perform Quality Assurance (QA)/Inspection for an aseptic processing and/or cGMP facility; 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 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. 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/12511429
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.