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Senior QA Technical Specialist (QA Systems and Compliance) in Morrisville, NC

Fujifilm Manufacturing USA, Inc

Morrisville, NC 27560
4d ago


Quality Management


8 - 10 years

Job Description

We are seeking a highly motivated individual to function as a Quality Assurance SME, with limited supervision, in our Contract Manufacturing site located in Research Triangle Park, NC. Primary responsibilities will be to support the QA Systems team responsible for monitoring Deviations, CAPAs, and Change Controls/management, performance of external audits/site inspections and readiness activities. Successful candidate will have a proven track record of leading teams and collaborating cross-functionally. Experience with change management review boards is a plus.

Essential Functions and Duties:

  • Function as the site SME for QA System matters. Can make decisions within the SOP, Standard practice, and regulatory framework for compliance areas in which they are an SME and can assist others in cross functional peer conflict resolution
  • Support QA Systems (Deviation, CAPA, Change Management, inspection/audit readiness) projects, and staff to meet sit
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Valid through: 2020-4-8

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