Quality Control Specialist

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.

• 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.

• 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.

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

• 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…