Job Description
Responsibilities
Leads and participates in formal problem-solving processes, conducts root cause and corrective action investigations for quality failures, including those occurring in supplier, in-house processes and Client-side findings. Supports the Director, RAQA for all Quality and Regulatory strategy plans, actions, implementation and upskilling as the Business grows. Leads overall site compliance efforts, including, but not limited to: Support for regulatory meetings with FDA. External health authority inspections and audit readiness and logistics. Front room audit host, RA/QA Subject Matter Authority, and/or backroom support. Key liaison for agency communications as the need arises. Lead followup activities for post-inspection root cause and correction action plan for identified corrections. Completion of essential functions includes the effective application of: Gage ...
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