QA Change Control Specialist

Braintree, MA
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 138398

Date Posted: 03/15/2019

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.

Position Summary:

  • 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


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