Quality Control Specialist I

Texas Biomedical Research Institute•San Antonio, TX

About The Position

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.

Requirements

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.
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.

Nice To Haves

Bachelor’s Degree from an accredited four-year college or university.
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.

Responsibilities

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.

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.