Quality Management Systems Specialist

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.
• Lead critical investigations using tools like 5-Why analysis and 6M methods.
• Attend daily process meetings (upstream/downstream) to...