QA/RA Compliance Specialist

A minimum of 3 years related experience in the pharmaceutical manufacturing industry. • Strong background working with Change Controls and management of change control processes. II. Basic Function: This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints; preparing annual product reviews, tracking and trending, and follow-up of the Change Control and CAPA programs. . This position interacts directly with manufacturing, engineering, product development, technical services, validation, etc. personnel and is responsible for the quality/regulatory feedback loop to those impacted areas. Also, this position will involve preparing filings to support site registrations and permits as well as regulatory submissions to the FDA, FL DBPR, and other worldwide agencies as needed to support Customer filings under the direction of the Supervisor.