About the job
As a Senior QA Compliance Specialist, you will play a crucial role in ensuring that our manufacturing facility adheres to all relevant regulations and standards. You will assist in managing our internal audit system, contributing to the quality and compliance of our production and support functions.
Key Responsibilities:
- Assist in the planning and execution of internal compliance audits across all operations, promoting a proactive approach to audit preparedness.
- Support the organization during inspections by regulatory agencies, such as the DEA and FDA.
- Ensure timely development and completion of action plans following audit findings.
- Contribute to management reviews and establish compliance performance metrics for the plant.
- Assist in the collection and analysis of metrics related to compliance corrective and preventive actions (CAPAs).
- Oversee supplier qualifications, including onboarding new suppliers and re-evaluating existing ones.
- Develop and enhance internal auditing processes.
- Maintain and update documentation to ensure compliance with industry standards.
- Support change management initiatives within the team.