Quality Control Specialist II

Texas Biomedical Research Institute•San Antonio, TX

43d

About The Position

We are seeking a Quality Control Specialist II to join our team. This position is responsible for performing detailed quality control reviews of research data, including non-GLP, GLP, and Animal Rule study records. The role also includes training QC personnel and assisting Study Directors with protocol development.

Requirements

Associate degree (60 semester hours) from an accredited institution required.
At least three years of experience reviewing preclinical research records for quality control.
Excellent written and verbal communication skills.
In-depth knowledge of FDA regulations related to GLP (21 CFR Part 58), Animal Rule, and electronic records (21 CFR Part 11).
Understanding of nonclinical/preclinical research protocols.
Familiarity with medical and scientific terminology.
Proficiency in Microsoft Word and Excel.
Strong attention to detail, with excellent spelling, grammar, and punctuation.

Nice To Haves

Bachelor’s degree preferred.

Responsibilities

Conduct comprehensive quality reviews of data and reports for completeness, accuracy, and compliance with minimal supervision.
Prepare clear, concise QC Review Reports for Study Directors.
Review and assess study-related processes and procedures.
Support Study Directors with study protocol development and review.
Assist during inspections by external monitoring authorities and study sponsors.
Help identify and implement corrective and preventive actions in response to inspection findings.
Meet regularly with Study Directors or Study Compliance Managers to report on study status, findings, and any compliance concerns.
Train and mentor Quality Control Specialist I personnel.
Serve as a key resource for quality-related issues across study teams.
Maintain organized, accurate study documentation.
Perform other quality control activities as assigned.
Prepare and send QC correspondence and documentation as needed.

Benefits

Recognized as one of the San Antonio Business Journal’s Best Places to Work in 2025.
Awarded the 2024 Healthy Workplace Platinum Recognition by the San Antonio Business Group on Health (SABGH).
Employee-centered culture with an emphasis on open communication, job empowerment and trust
Comprehensive health, dental, vision, and life insurance plans for your family (and even your pets
An incomparable employer funded retirement plan with 7% retirement funding starting day 1 (and increases upon years of service)!
Generous paid time off, with 14 paid holidays including Winter Recess (paid week off the last week of December)
On-site medical clinic, wellness incentives & paid prescription drug resources to promote health management!
On-site gym & wellness programs!
Flexible work arrangements for work-life balance!
We offer a relaxed dress code so you can feel comfortable and be yourself at work.
Dynamic learning environment with opportunities for professional development, mentorship, continuing education (tuition reimbursement) and leadership programs to help you thrive both personally and professionally.
We take pride in fostering a culture of respect, opportunity, and unity. Texas Biomedical Research Institute provides equal employment opportunities for all qualified employees and applicants without regard to race, color, sex, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.