Data Review Specialist, Quality Control

Role: Data Review Specialist in Quality Control within a biopharma setting, focusing on reviewing analytical chemistry, microbiology, stability, and device testing data to ensure compliance with cGMP, GLP, and data integrity standards. Responsibilities include thorough examination of laboratory raw data, trend analysis of stability and raw material data, supporting lot release, stability studies, and regulatory submissions, and collaborating across QC, QA, Manufacturing, and Development teams to resolve discrepancies and improve data processes. Requirements: Bachelor’s in Chemistry, Microbiology, or related field; 5+ years’ GMP laboratory or data review experience; strong knowledge of cGMP, GLP, ALCOA+; proficiency with chromatography software (e.g., Empower), LIMS, JPM, and data monitoring tools. Preferred: experience with method validation, stability protocols, and statistical software like JMP. High-Value: Biopharma, ophthalmic focus, supporting clinical and commercial batches, with an emphasis on data integrity, compliance, and cross-functional collaboration. Work setup details are not specified.