QC Specialist

About the role

Quality Control Specialists are operationally responsible for performing quality control activities associated with Biometrics client’s deliverables. They maintain a project‑level perspective, focus, and communicate effectively as the quality control subject‑matter expert.

Key responsibilities

• Perform quality control activities such as documentation review and testing of Rave EDC and data‑management deliverables, including eCRFs, validation specifications, custom functions, data extracts, integrations, mapping, and reports.
• Participate in designing and developing quality control procedures and manage documentation created during the QC process.
• Liaise with study teams and other staff to fulfill responsibilities and ensure deliverables are completed on time with high quality.
• Develop and lead training and knowledge‑transfer opportunities for the quality control team.
• Inform the manager of training issues, project activities, quality issues, and timelines as directed.

Required profile

• Four‑year college degree or higher in an analytic discipline (e.g., Computer Science, Health‑related field) and excellent English proficiency.
• Minimum 3‑5 years of experience in the pharmaceutical/biotechnology industry, with knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and industry standards (CDASH, SDTM) preferred.

Required skills

• Extensive knowledge of the Medidata Rave EDC platform.
• Familiarity with SQL Server and Oracle databases.
• Experience validating eCRFs, edit checks, custom functions, and data‑management reports.
• Proficiency in Microsoft Word, Excel, and PowerPoint.