Stability Study Reviewer

Eurofins USA BioPharma Services•Lancaster, PA

13h•Onsite

About The Position

Eurofins Lancaster Laboratories is seeking a highly analytical and quality‑driven Data Reviewer 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 Reviewer 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 deliverables.

Requirements

Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmaceutical Sciences, or related field) or equivalent industry experience.
Strong scientific comprehension and ability to interpret technical protocols, quotes, and study plans.
Exceptional attention to detail and commitment to data accuracy.
Strong communication skills with the ability to constructively collaborate and provide clear feedback.
Experience or familiarity with GMP, data integrity expectations, and regulated laboratory environments.
Ability to learn and work effectively within LIMS or similar informatics systems.

Responsibilities

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.
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.