Job Type

Full-time
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 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.
• 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 two or more years of experience performing quality control review of documents.
•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 pertaining to GLP (21 CFR Part 56), Animal Rule, and electronic records (21 CFR Part 11).
•Understands regulations governing the conduct of nonclinical/preclinical research protocols.
•Understands medical and scientific terminology.
•Excellent communication and interpersonal skills.
•Microsoft suite proficiency (Word/Excel).
Who We Are:
Texas Biomedical Research Institute is one of the world's leading independent biomedical research institutions dedicated to advancing global human health through innovative biomedical research. Texas Biomed aims to unravel the mysteries of infectious diseases through innovative thinking, creative problem solving and cutting-edge technologies.
What We Can Offer You:
•Competitive pay and career development opportunities
• 7% employer funded retirement contribution starting day one!
•Full insurance benefits
•14 Paid Holidays, PTO and a paid week off in the last week of December
•We are proud of our commitment to Diversity, Equity, Inclusion and Belonging!
Texas Biomedical Research Institute provides equal employment opportunities for all qualified employees and applicants without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.