Analytical Data Review Specialist

Position OverviewThe Analytical Data Review Specialist is responsible for ensuring the accuracy, integrity, and compliance of analytical data generated within the laboratory. This role performs independent data review of analytical testing (e.g., HPLC, LC-MS, ELISA, DLS, SV-AUC), verifies adherence to regulatory standards, and supports the release of high-quality client deliverables.The ideal candidate combines strong technical understanding of analytical methods with meticulous attention to detail and a working knowledge of GLP, GMP, and cGMP environments.Key ResponsibilitiesData Review & Quality ControlPerform independent second-person review of raw data, processed data, and reports for analytical studies. Verify accuracy of calculations, integrations, and data transcription. Ensure data integrity and compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate). Review applicable assay outputs for consistency and scientific validity. Identify discrepancies, deviations, or out-of-specification (OOS) results and escalate appropriately. Documentation & ComplianceReview laboratory documentation including: Analytical reports Laboratory notebooks / electronic records Ensure compliance with SOPs, study protocols, and regulatory requirements (FDA, EMA, ICH). Support cGMP documentation practices, including audit-ready records. Method & Study SupportCollaborate with applicable analytical team(s) (HPLC, LC-MS, ELISA, AUC, etc.) to ensure data is review-ready. Verify adherence to method qualification, validation, and release testing criteria. Support review of: Method development data Qualification/validation reports Stability and release testing data Quality Systems SupportAssist in activities and/or investigations related to: Deviations OOS results CAPAs Change ControlsContribute to continuous improvement of data review processes and QC workflows. Support internal and external audits by preparing and reviewing documentation. Cross-Functional CollaborationWork closely with: Analytical scientists QA team Project management Communicate findings clearly and constructively to ensure timely resolution of issues. QualificationsEducationBachelor’s degree in Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences or related life sciences field Experience1–4 years of experience in a: CRO or pharmaceutical/biotechnology laboratoryExperience with analytical techniques, such as: HPLC (SEC, IEX, RP, etc.) LC-MS ELISA DLS or AUC (preferred) Prior experience in data review, QC, or QA support strongly preferred. Technical SkillsProficiency in Microsoft Office, especially  Microsoft Excel and data analysis Knowledge of 21 CFR Part 11 and data integrity requirements (preferred) Core CompetenciesExceptional attention to detail and accuracy Strong critical thinking and problem-solving skills Ability to work independently while managing multiple priorities Clear and effective written and verbal communication Commitment to quality, compliance, and continuous improvement