Analytical Quality Assurance Associate/ Bio Chemist

Job description

Description Analytical QA Associate is responsible of providing analytical data review of QA Documents, support the development to ensure compliance with cGMP, FDA, Internal Policies, Procedures and Specifications. Responsible for the safe and efficient execution of job duties. Principle Accountabilities JOB DUTIES & RESPONSIBILITIES: Management Responsibility Reports to AQA Manager/Associate Manager Internal/External Contacts NA Knowledge & Skills - Part of analytical data review team according to the priorities. - Perform Data Review of Raw Material, Finished Product, Packaging Materials, In-Process, Finished Product, outside testing data, water testing data, Stability Samples, cleaning validation, swab analysis, equipment calibrations, IQ, OQ, PQ, Method Validations, Verifications of Drug Substance and Drug Product and cleaning methods (Electronic data, Notebooks, logbooks, Reports, and electronic sign off's) and notify Laboratory management or designee for any deviations, Out of Trend, extraneous peaks or out of specification result - Perform product review for analytical data. - Responsible for ensuring and performing Data review of Analytical R&D, FDA deficiencies, PDR report...