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 Investigator
  • Proactively 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.