Senior QC Specialist (GLP Studies – Product Safety Labs)

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.
Basic Minimum Qualifications (BMQ):
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.
Education/Experience (BMQ):
Bachelor’s degree in Toxicology, Biology, Pharmacology, Pharmaceutical Sciences, or related field; Master’s preferred.
8–12 years of experience in GLP-regulated environments, CRO operations, preclinical research, QA/QC, or study support.
Strong knowledge of GLP regulations, data integrity principles, and good documentation practices.

Employment type
Full-time

Work arrangement
No