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Quality Compliance Specialist - 1st Shift

Portsmouth, New Hampshire | Contract

Job ID: 47976 Industry: Manufacturing

This company is one of the world' s leading suppliers to the Pharma & Biotech industries!

They are now looking for a Quality Compliance Specialist

The Quality Compliance Specialist interacts directly with internal customers on change management documentation and projects. The role is to serve as the Subject Matter Expert and decision maker for change management throughout the facility. Capable of identifying, defending, and resolving Quality issues with appropriate supporting documentation. Quality Compliance must be able to weigh the risk of the event and look for the efficient yet compliant solution. The specialist will ensure superior customer service to internal customers.

Key Accountabilities and Duties:

Partner with internal customer as part of Change Control review serving as the Quality Subject Matter Expert.

Supporting the site on all change control from the areas of MSAT, Engineering, QC, Validation, and Manufacturing.

Attend meetings prepared to speak to the project/change and identify Quality requirements.

Reviewer and final approver on SOPs, forms, test methods, logs within Document Management System.

Responsibility is to ensure changes are justified; procedures are followed, and contain appropriate associated reference.
FDA, Quality

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