Quality Assurance Specialist III

Texas Biomedical Research Institute•San Antonio, TX

4d•Onsite

About The Position

Join our growing Quality team as a Quality Assurance Specialist III. This role will provide audit and regulatory compliance support for preclinical and animal studies.

Requirements

Bachelor’s degree in science, biochemistry, biology or related field from an accredited college/university required.
Minimum of Three (3) years of job-related experience required.
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.
Understand regulations governing the conduct of nonclinical/preclinical research protocols.
Understand medical and scientific terminology.

Nice To Haves

RQAP-GLP Registration preferred.
Specialized skills in Quality related work .
Specialized skills that may be technical or non-technical, such as research and analytical skills, composing non-routine documents and letters, and ability to use software in complex applications.

Responsibilities

Perform audits for GLP preclinical and Animal Rule Studies as assigned and assure that the facilities, equipment, personnel, methods, practices, records and controls are compliant with applicable federal regulations and Texas Biomed internal standards.
Complete facility-based, process-based, and study-specific audits; audit study protocols, data and records, and reports following written QAU SOPs, policies and directives.
Maintain copies of the Master Schedule of GLP Studies and Animal Rule Studies and all GLP and Animal Rule protocols regarding studies assigned.
Provide support for nonclinical/preclinical research studies including Quality review of data and reports and recommend corrective actions to study directors/principal investigators and/or study staff.
Perform Quality Assurance review of SOPs and associated forms for consistency, clarity and adherence to FDA GLP and Animal Rule regulations, and other regulatory standards for Texas Biomed.
Independently collaborate with specific functional groups providing guidance on SOPs (i.e. content, quality, SOP lifecycle) and address any documentation needs.
Provide support during regulatory inspections and internal functional group audits. Solid understanding of documents governing the inspection readiness.
Assist with management of employee training documentation to ensure that Texas Biomedical Research Institute employee training files contain current and complete training information to ensure regulatory compliance.
Assist in preparing materials for training programs and meetings.

Benefits

Comprehensive health, dental, vision, and life insurance coverage for you and your family—including pet insurance options.
Competitive employer-funded retirement plan with 6% contributions starting on day one, increasing with years of service.
Generous paid time off, including 14 paid holidays and a paid Winter Recess (from the last week of December through New Year’s).
Paid time off for short-term illness and mental wellness, helping you take the time you need when life happens.
Volunteer Time Off (VTO) to encourage giving back to the community.
Paid parental leave to support you and your growing family.
Flexible work arrangements that support a strong work-life balance.
On-site medical clinic, wellness incentives, and prescription support programs designed to make care more accessible and affordable.
On-site fitness center and wellness programs to help you stay active and healthy.
Relaxed dress code so you can feel comfortable and be yourself at work.
Dynamic learning environment with professional development opportunities, mentorship, tuition reimbursement, and leadership programs to support your growth.