The Quality Assurance 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, AABB, 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.

Duties

As a GS-1910-12 Quality Assurance Specialist (Cell and Gene Therapy), your duties may include but are not limited to the following: Assisting with the development and implementation of a Quality Systems approach to manufacturing of cell and gene therapy products that are 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 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, which includes process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency. Leading quality improvement processes based on best practices; identifying opportunities for improvement and providing leadership with the intention and implementation of projects to improve facility processes and meet customer needs. 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 CCE policies and procedures to ensure manufacturing and testing of cellular and gene therapy products processes are compliant. Drafting quality objectives with specific measurable activities and processes and quality assurance plans as needed for services performed and cell and gene therapy products.

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 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.
• 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.
• A one-year probationary period may be required upon selection/placement.

Qualifications

In order to qualify for a Quality Assurance Specialist (Cell and Gene Therapy), GS-1910 position at the GS 12 level, you must have: One year of specialized experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following tasks: Administering a Cellular Therapy Quality Assurance 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. 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12158784

Education

This job does not have an education qualification requirement.

Contacts

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