Job #10391: QA Change Specialist (369)
Title: QA Change Specialist (369)
Date Posted: 04/04/2019
Job Location: CANTON MA
The QA Specialist (Focusing on Change Control/ Risk management) will create, coordinate, and implement process changes and Risk management for the company’s manufacturing operations. This person will assist in managing the Change Control System, as well as handling updates to the Risk Management systems. This person will report to the Senior Manager, Quality Assurance and will be responsible for sustaining and improving engineering change control and risk management policies, procedures, and everyday practices.
This position will be instrumental in supporting a compliant and effective Quality Management System and 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. As system improvement opportunities surface, this person will be instrumental in aiding the Senior Manager, Quality Assurance to develop return on investment analyses, communication/project planning and the implementation of improvements. The QA Specialist (Focusing on Change Control/ Risk management) will support all functions in change management and risk management, across design changes and improvements, as well as manufacturing operations.
- 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.)
- Work with the assistance of the Senior QA specialist on assigned projects and tasks, effectively using other resources as needed to ensure timely support of the change control process.
- Receive and review requests for changes and determine form, fit, function related to regulatory requirements.
- Be accountable for ensuring that the risk and impact associated with each change is well defined and documented.
- Coordinate, contribute, design, and implement risk management strategies and programs.
- Facilitate and write Risk management Plans
- Monitor the status of open Risk Assessments, providing periodic reports and status updates on the overall performance of the Risk Management program.
- 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 likely be required to cross-train with other associates on broader quality system activities and processes.
- Other duties throughout the facility, as needed.
- Bachelor’s Degree. Biological Science or Engineering field and/or Quality Management is preferred.
- 3-5 years of recent, applicable GMP experience within the device/biologic/pharmaceutical industry owning or directly supporting a Change Control System and Risk Management systems, ideally in both an ISO and FDA/CDRH regulated quality system, with GMP experience in pharmaceutical or biotechnology industry is a plus.
- Must be highly proficient with Microsoft Word, Excel, PowerPoint, Access, and Risk management tools, etc.
- Quality training to include Risk management practices is preferred.
- Minimal travel required.