Analytical Laboratory Data Reviewer

Our client is looking for experienced Laboratory Data Reviewers II and III to join their team! This is a great opportunity for QC laboratory professionals with strong analytical instrumentation experience to take on a more technical, quality-focused role within a GMP environment.

FULLY ONSITE ROLE

Responsibilities

• Review QC testing and raw analytical data for accuracy, completeness, traceability, and compliance with specifications, SOPs, cGMP, and data integrity requirements.
• Perform technical review of compendial testing (USP/NF, EP, JP), in-house methods, and client-specific methodologies.
• Review data generated from analytical instrumentation including HPLC/UHPLC, GC, ICP-MS, IR, UV-Vis, DSC, Karl Fischer, dissolution, optical rotation, and particle size.
• Verify calculations, sample/standard/reagent traceability, instrument calibration, usage logs, and GDP compliance.
• Review and trend stability data, prepare stability summary tables, and identify unexpected or inconsistent results.
• Conduct electronic data reviews and signatures while ensuring complete and accurate documentation.
• Review testing performed by external/contract laboratories and coordinate testing for stability samples as needed.
• Support OOS investigations, deviations, CAPAs, change controls, and other Quality Management System activities.
• Author, review, and/or approve SOPs, test methods, forms, and other quality documents.
• Collaborate with laboratory personnel, QA, management, and other departments to resolve analytical issues and support client/customer discussions.
• Provide training and technical guidance to new and lower-level Data Reviewers.
• Support raw material release, GMP production suite commissioning, QA inspection/cleaning verification activities, and other quality initiatives as needed.
• Compile and trend data, prepare summaries for management, and report on laboratory performance and areas requiring improvement.

Qualifications

• Several years of QC analytical laboratory experience with hands-on use of laboratory instrumentation.
• Strong experience with HPLC, GC, UV, IR, particle size, and other analytical techniques.
• Experience working in a GMP/GDP-regulated environment with a strong understanding of data integrity.
• Pharmaceutical experience preferred; biotech, chemical, or other regulated laboratory experience considered.
• Experience with technical data review, stability testing, investigations, CAPAs, deviations, and/or quality systems strongly preferred.