Quality Control Analyst (HPLC)

Job Description We're looking for a detail-driven Quality Control Analyst (HPLC) with a strong foundation in GMP/GLP compliance, QMS activities, and audit readiness. Main Responsibilities: - Perform sampling and analytical testing of raw materials, finished goods, intermediates, water, and environmental monitoring samples according to approved monographs and SOPs, with result entry in analytical sheets, QA forms, and LIMS. - Investigate and report out-of-specification (OOS), out-of-trend (OOT), and borderline results, initiating LIRs and CAPAs as required. - Maintain 24/7 audit readiness and actively participate in internal, external, and regulatory audits. - Ensure instrument calibration, verification, and maintenance of reserved samples and storage chambers. - Maintain laboratory housekeeping, cGMP, GLP, and safety compliance standards, including 5-S practices. - Manage chemical stock records, standard reconciliation, and timely labeling of sampled, approved, and rejected materials. - Ensure data integrity compliance in online documentation and maintain awareness across the team regarding data integrity norms. - Support QC efficiency enhancement programs and analysis reduction initiatives. - Complete assigned training and participate in CAPA closure activities. - Perform additional duties as assigned by the QC Manager or Group Leader.