Compliance Analyst
SupplyCore Inc.
Job Level
SeniorLead
About the role
- Oversee and manage the investigation process for unplanned incidents.
- Support site ETS investigation processes and train ETS authors.
- Create and oversee training programs for ETS authors and reviewers.
- Support the site deviation management process and drive the rapid response model.
- Create and communicate metrics for Lincoln deviations.
- Drive process of cell teams and investigation management; track investigation due dates to ensure compliance.
- Work with Quality and Regulatory Compliance to improve compliance and efficiency.
- Support regulatory agency, customer, and internal audits.
- Assist with Root Cause Analysis for all investigations and implement DMAIC where applicable.
- Implement and maintain CAPA gate process across the site.
- Maintain Standard Operating Procedures and compliance with the Zoetis Quality standards.
- Provide comprehensive support for regulatory investigation and audit preparedness.
- Hours: 1st shift; overtime and weekends may be required.
Requirements
- B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience.
- Demonstrated knowledge of the Deviation Event Tracking System (ETS)
- Demonstrated knowledge of root cause analysis and DMAIC process.
- Trained ETS investigation author or reviewer.
- Green belt or Black belt preferred.
- Knowledge of USDA, FDA, and EU regulations
- Experience in change management processes, regulatory compliance, quality operations, manufacturing for vaccines and/or pharmaceutical manufacturing operations.
- Demonstrated problem solving and risk assessment/management skills.
- Organizational skills, attention to detail.
- Excellent verbal and written communication skills.
- Works effectively in a team-based environment.
- Ability to communicate effectively with Team Members to facilitate requests and review from all levels to meet due dates.
- Demonstrated ability to work with internal and external colleagues.
- Ability to sit, stand and walk; some travel may be required; occasional overtime/weekend work.
- All applicants must possess or obtain authorization to work in the US for Zoetis.
