Quality Assurance Coordinator - (US-NC-Durham - 27722)

Minimum Education: Tech School
Job Type: Full Time
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Merck & Co. Inc. established in 1891 is a global research-driven pharmaceutical company dedicated to putting patients first.



Join us and experience our culture first-hand - one of strong ethics & integrity diversified experiences and a resounding passion for improving human health. As part of our global team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.



The Quality Assurance Coordinator known within Merck as the IPT QA Coordinator is responsible for all Quality related functions that directly support the Durham VMF (Vaccine Manufacturing Facility) Integrated Process Team (IPT) and the site value stream map while actively supporting participating in and embracing an empowered team culture.

The initial focus for this position will be to provide the Quality support for the introduction of a new vaccine Formulation and Filliing facility at the Durham site to include quality oversight and execution of equipment and utilities qualification. Activities include but are not limited to the following: IQ/OQ quality review execution of Clean Utility and classified area qualifications support of the media challenge program SOP development and review direct support of regulatory inspections and audits and all other associated quality functions.




Requirements:

Bachelor degree in Science or Engineering.
Strong leadership and communication skills.

Preferred:

Qualifications of equipment through installation qualification and operational qualification
Quality Management within the SAP system.
Knowledge of CFR Eudralex and other regulatory guidance specific to the pharmaceutical industry.

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