Data Review – Specialist (Stability Protocol / Study Build Review)
Job Description
Position Summary: Eurofins Lancaster Laboratories is seeking a highly analytical and quality‑driven Data Reviewer Specialist to ensure accuracy and compliance of all stability protocols and study builds prior to client release. This position plays a crucial role in safeguarding data integrity and ensuring that client expectations are consistently met.
This role includes a structured training progression: the individual will be fully trained as a Stability Protocol Writer / Study Builder prior to performing protocol and study review responsibilities. This ensures a deep understanding of both the technical content and system workflows that impact the quality of client deliveries.
Key Responsibilities
Training Phase – Protocol Writing & Study Building
- Complete comprehensive training in protocol writing based on Eurofins‑generated quotes.
- Learn and practice building stability studies within the LIMS system following client‑provided protocols.
- Develop proficiency in interpreting client requirements, scientific documentation, and stability program workflows.
Primary Role – Data Review
- Perform detailed, independent review of stability protocols and study builds to ensure accuracy, completeness, and alignment with client expectations.
- Confirm that all protocol parameters (e.g., storage conditions, pull points, test plans) are correctly entered and consistent with both quotes and client-provided documents.
- Verify compliance with GMP, internal SOPs, and industry guidelines.
- Identify discrepancies, errors, or gaps and communicate effectively with Protocol Writers, Project Managers, and other stakeholders to resolve issues.
- Ensure documentation is traceable, audit-ready, and maintained in accordance with data integrity principles (ALCOA+).
- Support continuous improvements in review workflows, documentation standards, and system utilization.