45 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. INDBH #LI-BH1
