Quality Assurance Specialist

Quality Assurance Specialist

Venesco, LLC is looking for a Quality Assurance Specialist for our customer at the United States Institute for Surgical Research (USAISR) in San Antonio Texas. In this role you will work on observing research DOD research protocols for quality assurance adherence. Studies include animals such as swine, mice, primates, etc. Experience with Quality Assurance for Animal Studies is required.

The USAISR is part of the U.S. Army Medical Research and Development Command (USAMRDC). The USAISR is dedicated to both laboratory, pre-clinical, and clinical trauma research. Its mission is to provide requirements-driven combat casualty care medical solutions and products for injured soldiers from self-aid through definitive care across the full spectrum of military operations; provide state-of-the-art trauma, burn, and critical care to Department of Defense (DoD) beneficiaries around the world and civilians in our trauma region;

and provide Burn Special Medical Augmentation Response Teams.

The mission of the USAISR is Optimizing Combat Casualty Care. The USAISR accomplishes its mission through providing requirements driven innovative products and solutions in combat casualty care and, as the only Burn Center in the DoD, providing state of the art burn, trauma, and critical care to injured war fighters and DoD beneficiaries from around the world.

The Vision of the USAISR is to be the world's premier research organization enabling readiness and delivering evidence-based solutions for the optimal care of the combat wounded.

The USAISR is increasingly called upon to provide expert services related to battlefield traumatic injury and to burn care. The objective of the Quality Management Division (QMD) is to support quality-driven scientific research by providing post approval monitoring and auditing activities for human/animal subject research for both Federal Drug Administration (FDA) and Non-FDA regulated trials. The Institute is currently funded to perform research to evaluate the most advanced and promising technologies using the most clinically relevant and stringent animal models possible, and the QMD provides monitoring and reviews of all research in the USAISR to ensure highest quality of research as well as compliance with all regulatory laws, policy, and directives.

Responsibilities:

6.0 QAS Duties:

6.1 Key Task 1:
Implement and maintain QA using written regulations, policies, and SOPs to ensure that studies are conducted, and data generated/documented/reported in compliance with the approved protocol.

6.2 Key Task 2:
Audit ongoing research protocols and conduct on-site surveillance of the human subject's consenting process to ensure the investigators' practice is in conformance with applicable laws, regulations, directives, policies, and ethical principles.

6.3 Key Task 3:
Follow up on corrective actions of noted deficiencies and compliance related issues to ensure that the correction plans are in place and on schedule.

6.4 Key Task 4:
Monitor that each study is performed in compliance with Good Clinical Practices (GCP)/Good Laboratory Practices (GLP)/Good Manufacturing Practice (GMP) and all other applicable statutory and regulatory requirements.

6.5 Key Task 5:
Coordinate with investigators or other study personnel to conduct audits, prepare/maintain audit reports of ongoing research projects based on USAISR SOPs. Secure records of audits in one location for the length of time specified by regulations.

6.6 Key Task 6:
Review the final study report and documents to assure accurate disclosure of methods, SOPs and accurate reflection of raw data. Prepare a final audit statement that identifies the dates of inspections and the dates of when findings were reported to management IAW internal SOPs.

6.7 Key Task 7:
Routinely inspect/audit/observe systems of the study, processes (all operation required to conduct a study), procedures, such as personnel, equipment, SOPs and the laboratory.

6.8 Key Task 8:
Review each phase of the study, at appropriate intervals, to ensure the integrity of the study. Assist with continuing review reports and final reports to ensure thoroughness and completion of protocol.

6.9 Key Task 9:
Assist with the coordination, issuing, and annual review of investigators laboratory notebooks. Maintain an index of all notebooks issued at USAISR.

6.10 Key Task 10:
Assist with coordinating the completion of protocol closure and final report documents for research studies.

6.11 Key Task 11:
Provide training, as necessary, to USAISR personnel on a variety of topics such as those pertaining to research, quality improvement, documentation, techniques, FDA requirements, GCP, etc. Training shall be ad hoc sessions, small or individual sessions, didactic, hands-on, etc.

6.12 Key Task 12:
Comply with all DoD, U.S. Army, USAISR, and other Governmental regulatory requirements with special emphasis on safety and security. Contract personnel will be provided familiarization on USAISR orientation…