The Quality Specialist in the Quality Assurance department is responsible for critical independent reviews and QA release of auto injector products and Quality Assurance oversight of manufacturing activities which require a high level quality experience.
Providing leadership and direction related to strategizing, planning, implementing, monitoring, and reporting improvement activities to ensure Priority Healths contracts achieve ongoing improvement and maximize 5-star related opportunities.
This position coordinates the Quality Management system ensuring compliance to all relevant regulations and standards including ISO13485 and FDA QSR Part 820. This includes change management, record retention, training, and leading the internal audit program.
In this role, the selected candidate will align and maintain local SOPs and practices in accordance with applicable documentation requirements defined by 21 CFR Parts 211, 700 and 820; ISO 13485, and Akorn Quality System Policies (QSPs).