Quality Management Systems Specialist in New Jersey

This position involves managing key documentation processes within a dynamic manufacturing operations team in Piscataway, NJ. The role requires expertise in upstream and downstream biologics manufacturing processes, including cytokines and monoclonal antibody production. Responsibilities include creating, reviewing, and maintaining critical documentation to support compliance and operational excellence in a biopharmaceutical environment.

Responsibilities:

• Provide comprehensive documentation support, including reviewing executed batch records for both upstream and downstream processes.
• Prepare and manage change controls, deviations, and CAPAs for manufacturing operations.
• Utilize investigation tools (e.g., 5 Whys, 6M methods) for critical or major investigations.
• Attend daily meetings with process teams to identify and address documentation needs.
• Collaborate with QA to ensure timely closure of QMS-related...

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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