The QA Specialist is a key part of the Quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of the current Good Manufacturing Practice (cGMP) regulations. This role will ensure that the manufacturing team has direct and effective support to ensure manufacturing of Aerie products meets Right First Time espectations while maintaining a high standard of continuing compliance and process improvement.
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 all manufacturing deviations, CAPA‘s and associated processes and provide Monthly KPI’s on such.
· Assist in the completion of Customer Quality Complaint investigations as they relate to manufacturing
· Perform detailed batch record review of finished products prior to / for QP release.
· Quality Assurance oversight of in-process quality inspection within manufacturing/packaging.
· Assist in the execution of the internal audit program including the performance of audits as required.
· Review of batch record paperwork on the manufacturing shop floor and to manage of the control of SOPs and associated documents.
· Participates as required in training program development and implementation.
· Notifies manager of compliance questions and issues
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.