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.

Responsibilities:

• Provide post approval monitoring and auditing activities for clinical research, both FDA and Non-FDA regulated trials. The Contractor shall provide the following tasks:
• Implement and maintain quality assurance using written regulations, policies and standard operating procedures to ensure that studies are conducted, and data generated, documented, and reported are 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; conduct Root Cause Analysis and Corrective and Preventive Action (CAPA), lead CAPA teams.
• Ensure that planned and systematic actions are established, and that each study is performed in compliance with Good Clinical Practices/Good Laboratory Practices/Good Manufacturing Practice and all other applicable statutory and regulatory requirements.
• Coordinate with investigators or other study personnel to conduct audits, prepare and maintain audit reports of ongoing research projects based on ISR SOPs. Prepare and maintain reports of audit conducted. 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. Based on ISR 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.
• Assist with the development of standardized procedures and checklists for monitoring compliance of a study with Good Clinical Practices, Good Laboratory Practices and Good Manufacturing Practices as applicable, and all other pertinent regulatory requirements.
• 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. Maintains index of all notebooks issued at USAISR.
• Assist with the USAISR document control system; prepare documents for review and signature, maintain a tracking system for status of SOPs, issue SOPs electronically distribute revisions as required.
• Assist with coordinating the completion of protocol closure and final report documents for research studies at USAISR.
• Assist in developing training in a variety of topics such as those indicated below, as necessary. Provide for methods to assess competency and maintain supporting documentation. Competency assessment would be for pre-training, post-training, gap analysis, etc. Provide training to USAISR personnel on a variety of topics such as those pertaining to research, quality improvement, documentation, techniques, FDA requirements, GCP, etc. Training would include but not be limited to scientific seminars, quarterly training, ad hoc sessions, small group to individual sessions, written training in bulletins, didactic, hands-on, etc.
• Assist QMD in Quality Improvement Activities as required for USAISR, to include Quality Bulletin, and other communication and improvement activities.
• Assist QMD in Strategic Planning Activities.
• Contractor shall comply with all DOD, US Army, USAISR, and other Governmental regulatory requirements with special emphasis on safety and security. The contractor will be provided familiarization on ISR orientation.

Requirements:

• B.A or B.S degree in related field
• Experience with animal clinical trials
• 3-5 Years providing quality assurance on scientific research
• Research experience with animals (Swine, primates, mice, rats, etc.)

Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.

For more information on Venesco, LLC., visit https://venesco.com.