Perform chemical, physical, and analytical testing on raw materials, in-process samples, and finished goods using established test methods
Operate and maintain laboratory instrumentation such as HPLC, GC, FTIR, UV-Vis spectrophotometers, titrators, and other analytical equipment
Accurately document test results, calculations, and observations in laboratory notebooks and/or LIMS in accordance with GMP/GLP data integrity standards
Compare test results against approved specifications and report out-of-specification (OOS) or out-of-trend (OOT) results per established procedures
Prepare reagents, standards, and solutions needed for testing
Perform calibration, qualification, and routine maintenance of laboratory instruments; maintain calibration logs
Support investigations into OOS results, deviations, and customer complaints; assist with root cause analysis and CAPA documentation
Ensure compliance with SOPs, safety protocols, and regulatory requirements (FDA, USP, ISO, etc.)
Participate in method validation, method transfer, and stability testing programs as needed
Maintain a clean, organized, and safe laboratory work environment
Support internal and external audits by providing accurate documentation and test records
Collaborate with production, R&D, and regulatory teams to resolve quality issues
