Job Description
Summary About the Role
As a Quality Systems Engineer I (NC-CAPA), you will support site quality initiatives and compliance objectives by contributing to quality systems, investigations, validations, and continuous improvement activities.
Under close supervision, you will apply established procedures to ensure compliance with FDA, cGMP, and Quality System Regulations while supporting manufacturing operations and product quality.
Your Responsibilities
Support the development, review, and continuous improvement of the facility Quality Plan, manufacturing processes, and Quality System procedures.
Participate in the management and maintenance of Risk Management Files and support information exchange across facilities.
Prepare, review, and assist in the execution of process validations (IQ, OQ, PQ), validation protocols, final reports, and Engineering Change Orders (ECOs).
Maintain validation records to ensure ongoing compliance and relevance to process changes...