Quality Control Specialist I

Texas Biomedical Research Institute; San Antonio (TX); On-site; USD 42,000 - 66,000; Full time

Job summary

Texas Biomedical Research Institute is seeking a Quality Control Specialist I to perform data reviews, prepare QC reports, and ensure compliance across non-GLP, GLP, and Animal Rule studies. The role requires at least 2 years of QC review experience and an associate degree; a bachelor's degree is preferred.

The ideal candidate will be proficient in MS Office, strong in medical terminology, and able to communicate findings clearly to Study Directors.

Qualifications

• Minimum two years of QC reviews of documents/records.
• Associate Degree from an accredited technical/vocational institute, college, or university.
• Bachelor’s Degree from an accredited four-year college or university preferred.
• Knowledge of FDA GLP regulations (21 CFR Part 58), Animal Rule, and 21 CFR Part 11.
• Knowledge of regulations governing nonclinical/preclinical research protocols.
• Knowledge of medical and scientific terminology.
• Excellent written, verbal, communication and interpersonal skills.
• Proficiency with Microsoft Office Suite, particularly Word and Excel.

Responsibilities

• Performs quality review of data, summary tables, and reports for completeness, accuracy, and compliance.
• Prepares QC Review Reports with corrective actions required for the Study Director.
• Reviews and assesses study-related processes and procedures.
• Assists with maintaining corrections tracking.
• May assist during inspections by external monitoring authorities and study sponsors, and with corrective and preventative actions in response to observations.
• Meets regularly with Study Directors/Study Compliance Manager to report status, findings, and corrective actions.
• Identify deviations in experimental procedures, sample handling, or data reporting that may impact study integrity or regulatory compliance.
• Maintains organized documents pertaining to Animal Rule Studies.
• May participate in additional QC activities.

Skills

Quality control reviews

Medical/scientific terminology

Communication skills

MS Office (Word & Excel)

Data/records review

Education

Associate Degree

Bachelor's Degree preferred

Tools

Microsoft Office Suite

Job description

Description

Texas Biomedical is searching for an analytical and detail-oriented Quality Control Specialist I. The ideal candidate will have a strong background in data and/or records review, with a keen eye for detail and a commitment to ensuring quality control review of research data including non-GLP, GLP, and Animal Rule study records.

The Role:

• Performs quality review of data, summary tables, and reports for completeness, accuracy, and compliance
• Prepares clear, concise QC Review Reports, with corrective actions required, for the Study Director.
• Reviews and assesses study related processes and procedures.
• Assists with maintaining Maintains corrections tracking.
• May assist during inspections by external monitoring authorities and study sponsors, and with the identification and implementation of corrective and preventative actions in response to any observations.
• Meets regularly with the Study Directors/Study Compliance Manager to report the status of studies assigned and any findings, corrective actions and any potential compliance issues.
• Identify deviations in experimental procedures, sample handling, or data reporting that may impact study integrity or regulatory compliance.
• Maintains organized documents pertaining to Animal Rule Studies.
• May participate in additional Quality Control activities as assigned.
• Types or e-mails QC correspondence or other documents using a PC.

Our Ideal Candidate:

• Requires a minimum of two (2) years of experience performing quality control reviews of documents and/or records.
• Requires an Associate Degree from an accredited technical/vocational institute, college, or university.
• Preferred: Bachelor’s Degree from an accredited four-year college or university.
• Preferred: Knowledge of FDA regulations related to Good Laboratory Practice (GLP), including 21 CFR Part 58, the Animal Rule, and electronic records/electronic signatures under 21 CFR Part 11.
• Knowledge of regulations and requirements governing the conduct and documentation of nonclinical/preclinical research protocols.
• Knowledge of medical and scientific terminology.
• Excellent written, verbal, communication, and interpersonal skills.
• Proficiency with Microsoft Office Suite, particularly Word and Excel.

Who We Are:

Join our incredible mission to pave the way for a world free from the fear of infectious disease! Texas Biomedical Research Institute is pioneering and sharing scientific research to protect you, your families, and our global community from the threat of infectious diseases. Our scientific discoveries create breakthroughs in medical research to provide better overall global health.

• The highest-level biocontainment labs for infectious disease and biodefense research
• A federally-designated National Primate Research Center
• More than 85 years of discoveries advancing diagnostics, vaccines and therapies
• An entrepreneurial culture and specialized expertise in regulated science required for FDA approval

What We Can Offer You:

• Enjoy an employee-centered culture grounded in open communication, empowerment, and trust. We believe in working hard and having fun, offering 100+ culture events each year to bring our team together and keep the energy strong!
• 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.
• Proud recipient of the 2025 Healthy Workplace Platinum Recognition from the San Antonio Business Group on Health (SABGH)—the highest honor for employee-focused wellness initiatives.

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.