Quality Management Systems Specialist

Pharma Industry Update: A Manufacturing QMS Specialist position is available in South Plainfield, NJ.

Position Overview:

The Manufacturing QMS Specialist will play a critical role in ensuring smooth and compliant manufacturing operations by managing essential documentation processes. The position requires hands-on expertise in both Upstream (USP) and Downstream (DSP) biologics manufacturing processes, including cytokine and monoclonal antibody production.

Key Responsibilities:

• Act as the main support for the manufacturing team regarding all documentation needs.
• Review and manage executed batch records for upstream and downstream processes.
• File and oversee change controls, deviations, and CAPAs for the manufacturing department.
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