Quality Control Specialist II at Texas Biomedical Research Institute

San Antonio, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Feb, 26

Salary

0.0

Posted On

11 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Data Review, FDA Regulations, GLP, Animal Rule, Preclinical Research, Communication Skills, Attention to Detail, Microsoft Word, Microsoft Excel, Training, Protocol Development, Documentation, Corrective Actions, Mentoring, Scientific Terminology

Industry

Research Services

Description

Description 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. The Role: 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. Our Ideal Candidate: Education Associate degree (60 semester hours) from an accredited institution required. Bachelor’s degree preferred. Experience At least three years of experience reviewing preclinical research records for quality control. Skills and Knowledge 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. 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. Texas Biomed is the only independent, nonprofit infectious disease research institute in the U.S. to combine: The highest-level biocontainment labs for infectious disease and biodefense research A federally designated National Primate Research Center More than 80 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: 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.

Responsibilities

The Quality Control Specialist II conducts detailed quality control reviews of research data and prepares QC Review Reports for Study Directors. They also assist with protocol development and support during inspections by external authorities.