Senior Release Coordinator - Deviation Management - (US-PA-West Point - 19486)

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.



With guidance from the Quality Operations Deviation Management Manager and/or Director the Senior Release Coordinator - Deviation Management evaluates suitability of release of biological products to marketplace is a primary source of advice guidance and input regarding quality issues for internal and external customers and will partner with operations and appropriate technology groups to ensure that frequency of APRs especially recurring ones are reduced or eliminated by identifying and ensuring that effective corrective actions are implemented in a timely manner.



The inumbent will lead a matrix team of a Coordinator and Investigators to evaluate suitability of release of biological products to marketplace. Responsibilities include but are not limited to:

Reviewing atypical process reports and resolving issues within 30 days.
Mentoring APR Investigators in writing scientifically sound investigation reports which identify root cause and have appropriate corrective actions which prevent reoccurrence of the deviation event.
Quality testing laboratory results environmental monitoring data validation and quarantine status manufacturing process changes atypical process reports and investigations are used in determination of biological product release status.

Please note relocation assistance is not available for this position.


Required:

B.S. in an appropriate scientific or engineering field.
Minimum of 3 years experience in manufacturing/research environment or related field with proficiency in Biological manufacturing research & development and testing of biological products.
Must be knowledgeable of release regulatory and cGMP requirements.
Must have a broad based understanding of manufacturing from the bulk product state to final release testing.
Excellent analytical communication and interpersonal skills.
Demonstrated leadership competence.

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