Quality Control Specialist I: Data Integrity & Compliance

Texas Biomedical Research Institute; San Antonio (TX); Sur place; USD 42 000 - 66 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality control reviews

Medical/scientific terminology

Communication skills

MS Office (Word & Excel)

Data/records review

Formation

Associate Degree

Bachelor's Degree preferred

Outils

Microsoft Office Suite

Description du poste

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.