QA Operations Associate I - New Albany, OH

Quality Assurance Specialist This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. Essential Duties and Responsibilities: Achieve and maintain packaging line and inspection room clearance qualification Conduct accurate verifications and checks as well as accurate process inspections Conduct accurate packaging AQL inspections Identify out of specification product, ensuring segregation and escalation, as required Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. Conduct component and raw material release Conduct chart monitoring, ensuring escalation, as required Support product shipping activities and perform quality related oversight and verifications Generate logbooks and sheets/labels Review Bills of Materials Basic knowledge of cGMPs and supporting regulatory documents Achieve and maintain clean side gown and sterile side gown qualifications Achieve and maintain Class A qualification Perform room, area and equipment clearances. Participate in Media Fill and maintain qualification Able to perform tasks with minimal error rate. Perform any other tasks/duties as assigned by management. Msccn