Vacancy expired!
- Main task complaint investigations and annual product reviews Must have Bachelor's in sciences preferred
- Minitab exp or statistic software is a must Guru skill in Math or excel exp would work as well.
- Past exp - Medical device complaint or QA Specialist inspector and QC exp transitions well Must have
- Degree: Chem or math degrees work well but not required 2-3 years exp QC or QA specialist role.
- 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.
- Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required
- Provide regulatory impact assessment on all change controls as required.
Vacancy expired!