Maintain the effectiveness of Quality Management Systems to assure compliance with GMP:Manufacturing site Policies and ProceduresISO 13485 QMS, 21 CFR 820 QSRRelevant global quality systems.
Participates in the implementation of the Quality Management System.
Perform manufacturing QC processes in a timely manner including lot release testing and testing related to validation, qualification.
Calibration and maintenance of laboratory equipment and related systems, maintenance of laboratory equipment.
Assist in the development of QC/QA procedures, Protocols, reports, create and maintain QC/QA documentation for new and existing products, processes, and equipment.
Reviews, interprets, and evaluates analytical data, including raw data, of developmental, clinical, and commercial related products for accuracy and compliance within procedures and GxP requirements.
Monitors stability studies of developmental, cl...