Position Summary:
Eurofins Lancaster Laboratories is seeking a detail鈥憃riented and highly organized Stability Protocol Writer / Study Builder to join our team. This role is critical in supporting our stability program operations by transforming client requirements and Eurofins鈥慻enerated quotes into accurate, compliant protocols and complete study builds within the LIMS system.
The ideal candidate is comfortable navigating complex technical documents, working with cross鈥慺unctional teams, and ensuring all study components are aligned with Good Manufacturing Practices (GMP) and internal quality standards.
Key Responsibilities
- Translate Eurofins鈥慻enerated quotes into fully developed, compliant stability protocols within the LIMS system.
- Build stability studies based on client鈥憄rovided protocols, ensuring all parameters are configured accurately.
- Collaborate with Project Management, Study Management, and Laboratory teams to ensure protocols and studies reflect correct requirements and timelines.
- Verify that protocol content aligns with regulatory expectations, internal SOPs, and client specifications.
- Maintain meticulous documentation and version control throughout protocol creation and study build processes.
- Identify and communicate any discrepancies or missing information to internal stakeholders or clients.
- Support continuous process improvements related to protocol writing, workflow efficiency, and system utilization.
- Ensure daily work complies with GMP, data integrity expectations, and Eurofins quality standards.