Senior QC Specialist (GLP Studies – Product Safety Labs)
Core
Perform advanced quality control reviews of study data, documentation, and records for GLP-compliant preclinical studies to ensure accuracy, completeness, and inspection readiness.
Role type
Senior IC quality control specialist (GLP preclinical studies)
Builds
Audit-ready study files, data packages for reporting and archival
Domain
Life sciences / Preclinical research / GLP compliance
Required skills
GLP regulations knowledge, data integrity principles, good documentation practices, toxicology/biology/pharmacology background, complex dataset review, discrepancy identification, corrective action planning, process improvement, mentorship
Preferred skills
Master's degree in relevant field
Technologies
None stated
Responsibilities
Perform detailed QC reviews of laboratory data, worksheets, protocols, and study records; Conduct first-pass review of complex long-term study datasets; Identify documentation discrepancies, omissions, and data inconsistencies; Coordinate correction and resolution of quality issues; Review study trackers, shipping records, and chain-of-custody documents; Maintain audit-ready study files; Support preparation of study data packages; Trend recurring quality issues and recommend corrective actions; Develop and maintain QC checklists; Mentor support staff on documentation quality
Seniority
Senior, hands-on IC
