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USA-Compliance Specialist III (Manufacturing/Quality) 1st Shift

Company: The Fountain Group LLC
Location: Framingham
Posted on: November 20, 2022

Job Description:


Qualified Auditor: Leads Internal Audits of site departments and systems,
identifies areas at risk for external observations. Guides in the development of
responses to observations and provides approval for responses. Approve internal
audit and external regulatory agency related audit response and CAPAs. Work
closely with manufacturing, quality and support groups to develop effective
CAPA to reduce deviation reoccurrence and for continuous improvement.

Work under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy. Contribute to the completion of organizational projects and goals.

Basic Qualifications:
Years of Experience: 6 - 9 years of experience working in a regulated GMP environment
Bachelor's Degree in Science, Pharmacy or related discipline or Master's Degree
(Operations experience in one or more of the following areas: Quality Assurance,
Quality Control, Regulatory Affairs, Manufacturing, Technical Support, Engineering validation.)
Experience working with international regulatory authorities with demonstrated understanding of US and EU regulatory requirements
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Keywords: The Fountain Group LLC, Framingham , USA-Compliance Specialist III (Manufacturing/Quality) 1st Shift, Other , Framingham, Massachusetts

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