Data Reviewer - Biopharmaceuticals (GMP)
Core
Reviews routine and complex analytical data for pharmaceutical and biopharmaceutical compounds to ensure compliance with validated procedures, protocols, and GMP standards.
Role type
Senior IC data reviewer (GMP laboratory)
Builds
Quality-assured laboratory data and reports for clinical research and therapeutic development
Domain
Biopharmaceuticals / Clinical Research / GMP Compliance
Required skills
GMP/GLP regulatory knowledge, analytical data review, SOP adherence, chromatography understanding, laboratory procedure knowledge, data accuracy verification, process improvement, technical documentation
Preferred skills
Formal data review experience in GMP labs, chromatographic experience, training staff on review techniques
Technologies
Laboratory information systems, analytical databases, standard office equipment
Responsibilities
Evaluate laboratory data for compliance with analytical methods and client directives, review sample results for scientific soundness and completeness, communicate with lab staff to maintain documentation quality, deliver clear review findings noting deficiencies, escalate significant issues to supervisors, support process improvement initiatives
Seniority
Mid-level, hands-on IC
