Manager, Quality Assurance

A brief overviewThe Manager of Quality Assurance is responsible for operations related to quality assurance activities including manufacturing floor quality oversight, GMP documentation, batch record review, and batch release.What you will doOversee and support implementation of electronic document control modules (Master Control) and ERP system (SAP)GMP compliance improvementsWriting new and revising current standard operating procedures (SOPs), specifications, etc.Auditing production, materials management, and quality control functionsWriting internal audit reportsSupport customer & regulatory audits. Responding to audit observationsReviewing all GMP documentation, including BPRs, SOPs, Specifications, Protocol, and ReportsReviewing trending data, Change Controls, Deviations, and CAPA’sProblem resolutions with GMP systemsQualificationsBachelor’s degree in a science-related field, - chemical engineering, biology or equivalentMinimum of 5 years’ experience in a GMP/regulated industryMinimum of 3 years in a QA management roleExperience in GMP manufacturing environment - quality assurance and/or quality controlExperience with 21 CFR Parts 110, 111, 210, 211, ICH Q7Experience with GMP document controlExperience in both internal and external auditingAbility to work with regulatory agenciesStrong supervisory skills and technical writing skillsExcellent written and oral communication skillsBasic computer knowledge, including Microsoft Word, Excel, and PowerPointAbility to effectively organize, multitask, and work in a fast-paced, deadline-driven work environmentAbility to communicate in a proactive and solution-focused manner, including keeping management aware of potential issuesDetail-oriented with the ability to troubleshoot and resolve problemsAbility to work independently and manage one’s timeCommunicate effectively and ability to function well in a team environment

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