Analytical Data Review Scientist

Position Summary

The Analytical Data Review Scientist is responsible for analyzing, tracking, and reporting laboratory and business data to support Eagle Analytical’s operations, quality, and compliance objectives. This role combines data analytics, programming, and business intelligence with hands-on laboratory testing support, ensuring timely and accurate sample testing, data management, and documentation.

What You Will Do

• Review analytical data, chromatographic reports, calculations, and laboratory worksheets for completeness, accuracy, and compliance with cGMP, cGLP, ISO 17025, USP, A2LA, and internal SOPs.
• Electronically sign off on data as both author and reviewer, following established procedures to ensure data integrity and regulatory compliance.
• Perform technical review and approval of Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, ensuring results meet regulatory and quality standards prior to release.
• Maintain accurate and current documentation of laboratory activities, SOPs, and forms.
• Write, revise, and review SOPs and related forms in a timely manner as required.
• Support laboratory compliance audits, internal quality audits, and safety audits.
• Participate in investigations of deviations, errors, and discrepancies, and assist with CAPA plans and risk assessments.
• Communicate with laboratory staff to proactively address documentation quality and resolve deficiencies.
• Perform routine and non-routine chemical analyses using HPLC, UPLC, GC, and spectrophotometry, as needed, under limited supervision.
• Process raw data using laboratory information management systems (e.g., EagleTrax, Empower) and ensure proper documentation and traceability.
• Process and analyze data to generate reports to support laboratory operations, quality review activities, and timely release of results to clients and internal stakeholders.
• Provide consultative support to customers regarding technical questions related to testing, methods, or analytical results.
• Participate in team discussions and contribute to achieving laboratory goals.
• Stay current with emerging technology, instruments, and regulatory changes, with emphasis on HPLC and pharmaceutical analytical chemistry applications.
• Assist in training new hires in entry-level or laboratory support positions.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, Biochemistry, or a related science field.
• Minimum 2 years’ experience in a regulated pharmaceutical analytical laboratory, or equivalent combination of education and experience.
• Proficiency with analytical instruments (HPLC, UPLC, GC, UV/Vis spectrophotometer), including operation, troubleshooting, and maintenance.
• Experience with LIMS (e.g., Empower, EagleTrax) and electronic data review.
• Strong knowledge of cGMP, cGLP, ISO 17025, USP, A2LA, and data integrity principles.
• Experience with laboratory documentation, technical review of analytical data, and OOS/OOT investigations.
• Excellent attention to detail, organizational, and communication skills; ability to work independently and collaboratively.
• Proficiency in Microsoft Office.
• Experience with method development, validation, and transfer; familiarity with regulatory submissions and quality systems.
• Exposure to multiple laboratory workstations, cross-functional operations, and providing technical consultation is a plus.
• Knowledge of emerging analytical technologies and pharmaceutical testing applications.