Data Reviewer, Biosafety (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
Data Reviewer (GMP Laboratory)
Builds
Laboratory data reports and quality documentation for pharmaceutical clients
Domain
Biopharmaceuticals / GMP Laboratory
Required skills
GMP compliance knowledge, SOP adherence, analytical data review, chromatography knowledge, laboratory procedure understanding, quality documentation, regulatory knowledge (GLP/GMP)
Preferred skills
Formal data review experience in GMP Lab, chromatography expertise, process improvement initiatives
Technologies
Laboratory databases, analytical software, office equipment
Responsibilities
Evaluates laboratory data for compliance with analytical methods and SOPs; Reviews sample results for scientific soundness and accuracy; Communicates with lab staff to maintain documentation quality; Escalates significant deficiencies to supervisors; Facilitates conversations on best documentation practices; Identifies and supports process improvement initiatives.
Seniority
Mid-level, hands-on IC
