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The Quality Assurance Quality Management System ( QMS ) Specialist is responsible for maintenance of the quality management system located in Piscataway, NJ. The role requires a thorough knowledge of laboratory practices, including testing and OOS investigations, and Quality Management Systems ( QMS ) such as Deviations, CAPAs, and Change Controls. This person will be responsible for ensuring that quality control and manufacturing operations have appropriate QA oversight in terms of Quality Management System, including identification and management of Nonconformances, OOS Investigations, and Deviations. The Quality Management System ( QMS ) Specialist will be expected to drive continuous improvement initiatives and be capable of assessing and improving existing systems. The incumbent will be responsible for Quality Management System functions of Quality Assurance, including providing guidance in support of both late-stage clinical and commercial biosimilar and novel Biologic products, cGMP-compliant laboratories, and manufacturing operations.
The candidate needs to be highly motivated, well-organized, and detail-oriented Quality personnel who can work effectively in a fast-paced and multi-disciplinary environment.
Essential Duties & Responsibilities
Requirements
Education:
#MedixLS