Quality Assurance Specialist

VENESCO, LLC•Bandera, TX

2d•$65,000 - $75,000•Onsite

About The Position

Venesco, LLC is seeking a Quality Assurance Specialist to support the United States Institute for Surgical Research (USAISR) in San Antonio, Texas. This role involves observing research DOD research protocols for quality assurance adherence, including studies with animals such as swine, mice, and primates. Experience with Quality Assurance for Animal Studies is required. The USAISR, part of the U.S. Army Medical Research and Development Command (USAMRDC), is dedicated to laboratory, pre-clinical, and clinical trauma research, aiming to provide medical solutions and products for injured soldiers and optimize combat casualty care. The Quality Management Division (QMD) supports quality-driven scientific research through post-approval monitoring and auditing of human/animal subject research for both FDA and Non-FDA regulated trials, ensuring compliance with all regulatory laws, policies, and directives.

Requirements

Bachelors Degree in Biology, Microbiology, Biomedical Engineering or other life science or related field.
Must have completed training or experience in Good Laboratory Practice and Animal Care and Use Quality Assurance.
Three years of experience working in life science laboratory using animal protocols.
Highly Experienced with SharePoint, Microsoft Office and G-Suite Applications.
Able to write detailed reports and notices with clear, concise communication.
Collaborative and works well with others.

Nice To Haves

Two years of experience conducting Quality Assurance reviews is preferred.

Responsibilities

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.
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.
Follow up on corrective actions of noted deficiencies and compliance related issues to ensure that the correction plans are in place and on schedule.
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.
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.
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.
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.
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.
Assist with the coordination, issuing, and annual review of investigators laboratory notebooks. Maintain an index of all notebooks issued at USAISR.
Assist with coordinating the completion of protocol closure and final report documents for research studies.
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.
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 (directorate, department, location of fire extinguishers, fire alarms, egress during emergencies, and rally points).