Quality Assurance Senior Specialist

Serán is seeking a Quality Assurance Senior Specialist who will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing, storing, and testing pharmaceutical products.  Primary responsibilities include overseeing Supplier Quality, Auditing (supporting regulatory and client audits, conducting internal and vendor audits), and managing the Quality Risk Management program.

Tasks include audit management, audit response, facilitating audit related continuous improvements, negotiating/processing Quality Agreements and continuous improvement.  Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA.

Duties & Responsibilities: Performs internal and third-party audits.

Supports regulatory inspections and client audits.  Manages and improves audit program.