The Quality Assurance Specialist II is responsible for providing quality assurance auditing support for GLP preclinical and Animal Rule studies as required by FDA regulations and Texas Biomed internal standards with oversight by the QA Director. Supplies regulatory compliance support in the development of the Institute’s GLP Compliance Program. Other responsibilities of the incumbent are to provide regulatory compliance guidance to management, study directors / investigators, and feedback to Quality Management Systems (QMS) processes, including oversight of the Training Record Program.
- Perform compliance audits for GLP preclinical and Animal Rule Studies as assigned by the QA Director to assure management that the facilities, equipment, personnel, methods, practices, records and controls are in compliance with applicable federal regulations and Texas Biomed internal standards
- Support facility-based, process-based, and study-specific audits; audits study protocols, data and records, and reports following written QAU SOPs as assigned by the QA Director
- Determines that no deviations from approved protocols or SOPs were made without proper authorization and documentation for studies assigned
- Prepares clear, concise audit and inspection reports, and/or periodic written status reports for each study audited, noting any problems and the corrective actions taken; prepares the QA Statements to be included in the final study reports which specify the dates inspections were made and findings reported to management and to the study director for each study assigned
- Maintains copies of all GLP and Animal Rule protocols for studies assigned
- Maintains orderly, indexed QAU records files and archives QAU records at the end of each study for studies assigned
- Meets regularly with the QA Director to report the status of studies assigned and any findings and corrective actions and to apprise the QA Director of any potential compliance issues
- Advises management, supervisors, and administrative staff of compliance concerns
- May assist during inspections of the GLP Program by external monitoring authorities and study sponsors, and with the identification and implementation of corrective and preventative actions in response to any observations
Training Records & File Maintenance:
- Manage and develop the Training Record Program to ensure that Texas Biomedical Research Institute/SNPRC employee training files contain current and complete training information to ensure regulatory compliance (e.g., resumes or CV’s, job descriptions, training documentation such as sign-in sheets and quizzes, and Standard Operating Procedure Training and Proficiency).
- Assists in preparing materials for training programs and meetings, as needed
- Performs other duties as assigned.
EDUCATION/EXPERIENCE/SKILLS: Requires: Bachelor’s degree in Biology/Chemistry or related field. Requires two years or more of job specific experience. Experience with Good Laboratory Practice standards and experience working in a GLP regulated research environment. Experience in QA or QC, with focus on bioanalytical laboratory assays. Any equivalent combination of education and experience. Preferred: RQAP-GLP Registration
POTENTIAL HAZARDS: Work is performed within routine office environment as well as audits performed in laboratory and animal husbandry environments with potential exposure to hazardous or unpleasant conditions. Facility, process or study specific inspections may involve potential exposure to unpleasant odors, research animals, their waste, tissues and body fluids. May have potential exposure to hazardous chemicals and temperature extreme environments. Physical demands are usually limited to sitting or standing in one location much of the time. Some stooping, lifting or carrying objects of light weight may be required. Participation in a medical monitoring and surveillance program is required including a negative TB test.
OTHER: This is a full-time hourly paid position. Texas Biomed business hours are Mondays through Fridays 8:00 a.m. to 5:00 p.m. Texas Biomed is committed to a drug-free workplace. Pre-employment drug screen is required.
Application packets are accepted electronically or in hard copy. A completed application packet is a requirement for all positions. Incomplete applications will not be accepted. Equal Employment Opportunity/M/F/Disability/Protected Veteran Status
Your resume and application must be provided electronically. Please follow the steps below.
- Please read instructions before submitting your application.
- PDF forms will need to be completed, saved to your computer and uploaded. Please refer to Step 2 for additional information.
- Fill out the online form.
- At the conclusion of the application process, you will be asked to attach your PDF files.