Quality Assurance Specialist - (Irvine, CA)

The QA Specialist is a key part of the Quality team ensuring the site has a strong compliance and knowledge pharmaceutical base which is aligned with the principles and expectations of the current Good Manufacturing Practice (cGMP) regulations. This role will ensure that the site establishes and maintains the procedures and specifications that affect the quality of Aerie's products. They will also provide support and a knowledge base in all aspects of cGMP in relation to Deviation, CAPA, Change control and Audit Support Essential Duties, Functions and Responsibilities: Works with manufacturing, technical and other quality colleagues as part of a team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site. Manages the Change Request System, Deviation System, CAPA System and provide Monthly KPI on such. Assist in the management of Customer Quality Complaints & Pharmacovigilance systems Perform detailed batch record review of finished products prior to QP release.