Specialist Qa

Specialist QA with experience in regulated industry to review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing documents and records.Duties: Batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation's, CAPAs, and validations.Supports internal/external audits and inspections as part of the audit/inspection management team.Provides support and oversight of New Product Introduction (NPI)Requisitos:Doctorate degree or Master's degree and 3 years of directly related experience orBachelor's degree and 5 years of directly related experience orAssociate's degree and 10 years of directly related experience orHigh school diploma / GED and 12 years of directly related experienceBilingual (Spanish/English)(Write/Speak)Technical Writing Knowledge in CAPA, Non-conformance and Change Control (Quality System)Knowledge CSVExperience QA, QAL, and Process DevelopmentValidation Experience (IQ, OQ, PQ).Commissioning and Qualification experience Computer Literacy