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FDA Compliance Specialist

Company: Global Channel Management,Inc
Location: Rochester
Posted on: January 13, 2022

Job Description:

FDA Compliance Specialist needs 5-10 years experience.
FDA Compliance Specialist requires:
skills and ability to meet tight deadlines
Associates Degree Required, Bachelor's Degree Preferred
Knowledge of QMS elements, CAPAs, Root Cause Investigations, Audit Management, FDA and ISO regulations.
Proficient in Microsoft Office Applications
Ability to Multitask and Prioritize work,

FDA Compliance Specialist duties:
support audit and inspection readiness activities of the global quality system and processes in order to assure each area is able to successfully demonstrate compliance during internal and external inspections.
liaise with Regional QRC partners in order to collect, analyze and share information associated with annual audit activities across Company, in order to assure visibility and consistency across the QRC organization.
support the Global Compliance team in the coordination of both internal and external audits.
assist in the preparation activities for the strategy and logistics prior to audits and assist with post inspection activities (End to End coordination).
assist in the tracking of management commitments to assure timely and adequate follow-up activities.
Attend compliance meetings and track progress of action items.
Track global audit results and communicate them throughout the organization.

Keywords: Global Channel Management,Inc, Rochester , FDA Compliance Specialist, Other , Rochester, New York

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