Summary:Perform tactical work and review a variety of documents, protocols, and reports.Project Details:Exhibit varying levels of experience and a solid progression of work and/or trainingDocument, review and batch disposition of API and drug product used in Phase 1-3 clinical studiesReview and approve manufacturing records, change controls, investigations and analytical dataReview and approve test methods and method validationsReview manufacturing validation protocol and reportsJob Experience:Experience in small molecule manufacturing and contract manufacturingBachelor's degree in Engineering, Chemistry, Biology, or other related disciplineA minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical companyKnowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc.Excellent verbal and written communication skillsDemonstrate ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is criticalStrong analytical skillsEffective project management and organizational skills are essentialKnowledge and understanding of qualityManufacturing processes and procedures, planning, supply chain, inventory managementHourly Rate: 55.25-71.5

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