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Quality Systems Manager

Company: Cognate BioServices
Location: Memphis
Posted on: January 16, 2022

Job Description:

POSITION SUMMARY:This position reports to the Associate Director, Quality Systems and will be responsible for supporting the development, implementation and improvement of current and future Quality Management Systems including Document Control, Change Control, Nonconformance Investigations, CAPA, Training, Supplier Quality, Internal Auditing, Quality Management Review (QMR), and Risk Management.----------ESSENTIAL DUTIES AND RESPONSIBILITIES:1.----------Manage the implementation, maintenance, and improvement of Quality Systems based on established direction and priorities.2.----------Lead, support, and perform activities in the following areas: Internal Quality Audits, Supplier Audits, CAPA, Nonconformance Investigations, Quality Management Reviews, Document Control, Change Control, Risk Management, and Training.3.----------Compile and report key performance indicators, metrics and compliance status of Quality Systems for Management Review.4.----------Provide exceptional customer service to Cognate's internal and external customers in all assigned tasks and foster a GMP compliance culture.5.----------Establish and maintain a continuous improvement program.6.----------Assist with Training on GDP/GMP and other quality-related topics.7.----------Ensure compliance to quality policies, procedures, and governing regulations.8.----------Represent Quality Department during regulatory inspections, client audits, and various cross-functional meetings, as needed.--EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:1.--Minimum BS/BA Life Sciences or related field.2.--Minimum 3-5 years experience in a biologics, pharmaceutical, medical device, or related industry.3.--Ability to work independently and in a group on a variety of projects.4.--Ability to maintain a high degree of accuracy and attention to detail.5.--Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.6.--Ability to monitor and report on assigned tasks, goals, and objectives.7.--Competency with electronic document managements systems, preferably MasterControl.8.--Proficiency in Microsoft Office (Word, Excel, Outlook, etc.).

Keywords: Cognate BioServices, Memphis , Quality Systems Manager, Executive , Memphis, Tennessee

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