Compliance Auditor

A large Suffolk based manufacturer seeks an addition to their team.  Day to Day Responsibilities:Actively engage with different departments in the organization as a Lead InvestigatorProactively assists to identify and facilitate resolution of events to timely completion

Proactively manages progression of event investigations  Determines the risk and measurement in order to monitor the corrective action effectiveness.Preparation of reports for management

Lead the Internal Audit process

Prepare and perform annual internal audits of multiple departments for compliance.Performs all responsibilities in accordance with company policies, procedures, and all regulatory standards and regulations.Follows all safety procedures, policies, and precautions.All other duties as assigned

Required Skills and Abilities:Prior experience in utilizing formal Root Cause Analysis tools for event investigations

Demonstrates basic project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required.Excellent verbal & written communications skills, including ability to present information clearly and concisely are required

Excellent interpersonal and collaboration skills necessary to interface with all levels of the organization are required

General computer knowledge/skills Proficient in Word and Excel.Knowledge of Outlook and PowerPoint.Knowledge of Adobe Acrobat preferred

Physical Requirements:Ability to sit at a workstation for multiple hours.Some travel within Suffolk required.Minimum Education or Experience Required:Position requires a bachelor's degree in science, or related experience.Minimum 3 years' experience in an equivalent role within an FDA regulated environment preferred. 

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