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QA Associate

Company: Integrated Resources, Inc
Location: Morristown
Posted on: September 22, 2022

Job Description:

Job DescriptionTitle: QA AssociateLocation: Morristown, NJDuration: 6 Months Responsibilities: This position is responsible for maintaining and improving Client's Quality Management Systems with respect to Product Quality Complaints, Deviations, QEs/CAPAs, Change Controls and Document Management.This role will report directly to the Associate Director of Quality Systems in NY and has visibility to Sr/Executive leadership.The role itself is holistic in nature and knowledge about all aspects of Quality Systems and their interactions with various GxPs is expected. Essential Functions: Liaise with Client's QA and other departments to maintain compliance to the Client's Quality Systems, specifically:Oversee Change Control process through the entire change life cycle. o Aid in review and completion of product quality complaints.Facilitate Quality Event and CAPA review sessions, actively follow up on overdue deviations.Assist Document Management in day-to-day activities. (e.g., user access management, closure of tasks, etc.).Preparation of quality trend/metrics (for QE/CAPA, Doc Control, Complaints and Change Controls),Other duties as assigned. Required Knowledge and Abilities: Experience / knowledge of in the following:GxPs - GCP, GMP and GDP Quality Systems appropriate for late phase Clinical Development and Commercial Drug Product.Applicable CFR, ICH, EU, and GxP regulations.Skills in the following areas:Must be able to take initiative, work independently and prioritize workload.Good, collaborative interpersonal skills, positive attitude, and problem solving capabilities o Strong verbal and written communication skills are essential.Excellent organization and multi-tasking skills.Attention to detail is a must.Proficient in the following areas and computer applications:Master Control, Veeva Quality Docs or similar o SharePoint / Power BIMicrosoft Office Suite (Excel, PowerPoint and Word) Qualifications: BSc/BA in Organic Chemistry, Biochemistry, Applied Biology, Pharmacology or a relevant science5 years of pharmaceutical drug QA experience, specifically in quality system operations.

Keywords: Integrated Resources, Inc, Newark , QA Associate, Other , Morristown, New Jersey

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