QA Operations Associate I - New Albany, OH

Quality Assurance SpecialistThis 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 qualificationConduct accurate verifications and checks as well as accurate process inspectionsConduct accurate packaging AQL inspectionsIdentify out of specification product, ensuring segregation and escalation, as requiredEnsure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirementsEnsure 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 releaseConduct chart monitoring, ensuring escalation, as requiredSupport product shipping activities and perform quality related oversight and verificationsGenerate logbooks and sheets/labelsReview Bills of MaterialsBasic knowledge of cGMPs and supporting regulatory documentsAchieve and maintain clean side gown and sterile side gown qualificationsAchieve and maintain Class A qualificationPerform room, area and equipment clearances.Participate in Media Fill and maintain qualificationAble to perform tasks with minimal error rate.Perform any other tasks/duties as assigned by management. Msccn