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.

Qualifications :

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):

• Bachelors degree in Toxicology Biology Pharmacology Pharmaceutical Sciences or related field; Masters preferred.
• 812 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.

Additional Information :

All candidate CVs and cover letters will be reviewed however please note that we are not always able to respond to every expression of interest submitted.  

Remote Work :

No

Employment Type :

Full-time