Category: Scientific & Clinical
QA Change Control Specialist II/III
- BS in Biological Science or Engineering field and/or Quality Management is preferred
- 3-5 years of recent GMP experience within the device/biologic/pharma industry owning or directly supporting a Change Control System & Risk Management systems, ideally in both an ISO & FDA/CDRH regulated quality system.
- Quality training in Risk management practices is preferred.
- Must be highly proficient with Microsoft Word, Excel, PowerPoint, Access and Risk management tools.
- Monitor the status of open Risk Assessments, providing periodic reports and status updates on the overall performance of the Risk Management program.
- Ensure that changes are performed in an effective manner and are recorded, evaluated, authorized, prioritized, planned, documented, communicated, tested, and implemented properly.
- Monitor Quality Management Systems (Non-Conforming, Deviation, CAPA, Internal Audit, etc.) for potential changes and to measure the effectiveness of the Change Control
- Coordinates product and process changes with all relevant departments (Engineering, Operations, Purchasing, Compliance, Business Units, etc.)
- Coordinate Annual Design reports, Post market Surveillance reports, Annual Product Reviews and Product Quality Reviews
- Identify and implement opportunities for Continuous Quality Improvements by monitoring evolving regulations and best practices.
- Will be instrumental in supporting a compliant and effective Quality Management System, ensuring business and manufacturing systems related to the change order and risk management process are operating in a manner to facilitate effective and efficient business operations
Location: Braintree, MA
Duration: Direct Hire