Senior QC Specialist (GLP Studies – Product Safety Labs)
Job Description
Position Summary:
The Senior QC Specialist performs advanced quality control reviews of study data, documentation, and records supporting GLP-compliant preclinical studies. The role ensures study records are accurate, complete, consistent, and inspection-ready before Study Director review while supporting continuous improvement and data integrity initiatives.
Essential Duties and Responsibilities:
- Perform detailed QC reviews of laboratory data (acute toxicology data), worksheets, protocols, amendments, and study records.
- Conduct first-pass review of complex and long-term study datasets.
- Identify documentation discrepancies, omissions, transcription errors, and data inconsistencies.
- Coordinate correction and resolution of quality issues and verify completion.
- Review study trackers, shipping records, chain-of-custody documents, and supporting study documentation.
- Maintain audit-ready study files and records.
- Support preparation of study data packages for reporting, archival, and inspection readiness.
- Trend recurring quality issues and recommend corrective and preventive actions.
- Develop and maintain QC checklists and review standards.
- Mentor support staff regarding documentation quality expectations.
- Participate in process improvement initiatives.
- Escalate significant scientific, regulatory, or quality issues appropriately.