Groton, CT, United States (Hybrid)
Contract (10 months)
Published 1 day ago
Keywords: quality control, pathology, Environmental Health and Safety (EHS), clinical pathology data, compliance, GLP, Research, DSRD.
Summary: The Global Pathology Quality Control Scientist is responsible for independently conducting comprehensive quality control (QC) review activities for anatomic and/or clinical pathology data, specimens, and reports supporting GLP and non-GLP studies. This role plays a critical part in ensuring the integrity, accuracy, and compliance of pathology data used to support candidate selection, first-in-human studies, early research, target safety evaluations, and investigative studies.
The ideal candidate brings strong GLP experience, exceptional attention to detail, and proven expertise in pathology report review and QC processes. This position operates within a collaborative but primarily independent work environment and requires the ability to manage repetitive review tasks with a high degree of accuracy and consistency.
Job Responsibilities
Quality Control & Scientific Review
- Independently perform quality control review of:
- Anatomic pathology reports
- Clinical pathology reports
- Microscopic pathology data
- Histology data and documentation
- Conduct detailed report review and verification to ensure scientific accuracy, consistency, completeness, and compliance.
- Perform QC review activities for both GLP and non-GLP studies.
- Generate and review clinical pathology tables and related study documentation.
- Assist with drafting and maintaining pathology report templates.
- Contribute to publication data integrity QC activities within DSRD.
- Ensure all deliverables are completed according to established study timelines.
Regulatory & Compliance Responsibilities
- Perform all responsibilities in compliance with Standard Operating Procedures (SOPs), Good Laboratory Practices (GLP), Environmental Health & Safety (EHS) requirements, animal welfare regulations, and departmental policies and procedures.
- Maintain accurate, audit-ready documentation and records.
Operational Support
- Support pathology scheduling and workflow coordination activities as needed.
- Collaborate with pathology scientists, laboratory personnel, and project teams to resolve QC findings and maintain data quality standards.
- Participate in continuous process improvement initiatives.
Required Qualifications
Education & Experience
- Bachelor’s degree in Biology or related scientific discipline required, or Masters degree.
- 5-7+ years of relevant pathology or laboratory science experience.
- Minimum 5 years of experience in a GLP-regulated environment.
- Minimum 5 years of experience performing quality control or quality review activities.
Required Skills & Technical Experience
- Strong experience with GLP compliance, quality control review processes, scientific report review, and attention to detail and data accuracy.
- Knowledge of one or more relevant disciplines: Histology, Clinical pathology, Necropsy.
- Experience reviewing microscopic pathology and histology data preferred.
Pay Rate Range
- Min Pay Rate: $50 per hour
- Max Pay Rate: $55 per hour
- Currency: USD
- Unit: hourly
Benefits Information
- Comprehensive Benefits Package available based on eligibility
- Short-Term Disability (STD)
- Long-Term Disability (LTD)
- Supplemental and Voluntary Life Insurance