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.
Job Posted by ApplicantPro