Qa Specialist Iii (Req1157)

Qa Specialist Iii (Req1157)
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(Confidential)


Qa Specialist Iii (Req1157)

Details of the offer

QA Specialist III Job ID: req1157 Employee Type: exempt full:time
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first:in:human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the publics interest.

Position Overview:

PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., the Clinical Research Directorate (CRD), various clinical support teams provide high:quality comprehensive and strategic operational support to the high:profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRDs support services are strategically aligned with the programs mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CRD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CRDs collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the programs mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Research Directorate (CRD) provides support of Quality Assurance and regulatory compliance activities pertaining to the manufacture of retroviral vectors and cell therapies under cGMP and GTP requirements applicable to Phase I/II clinical trials as outlined primarily in 21 CFR 210.1, 211.113, 610.12, 1271, and FDA Guidance for Industry documents.

KEY ROLES/RESPONSIBILITIES
Assists in providing regulatory guidance and QA/compliance support for manufacturing of, and clinical research with, investigational drugs, biologics or devices for use in clinical studies (ie,manufacturing and clinical research) Attends meetings with other staff to represent NCI Surgery Branch (SB) in developing strategies for engaging and responding to concerns of these authorities, including the planning and execution of such negotiations Participates with regulatory agencies on defined matters Reviews documents for completeness; and provides essential information for specialists and researchers; track and monitor assigned projects Assists with audits from regulatory agencies and perf


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