Job Description

The Manufacturing QMS (Quality Management System) Specialist will be executing routine documentation work, which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPA, etc. This position requires technical expertise in upstream and downstream processes of biologics (Cytokines, monoclonal antibodies manufacturing).
 

Essential Duties & Responsibilities 
 

• Will be responsible for supporting the manufacturing team with a wide variety of documentation. 
• Documentation includes reviewing executed batch records, logbooks, and other associated documents, both Upstream department and Downstream batch records. 
• Will be responsible for filing change controls, deviations, and CAPAs for the manufacturing department. 
• For all critical/major investigation, will have to use investigation tools like 5why or 6M method.
• Attend daily meetings with both upstream and downstream processes to get all the documentation requirements for the day.
• Will meet weekly with QA to avoid any delay in the QMS closure.
• Will author batch records, SOPs, and associated forms/formats required for the manufacturing process.
• Will be responsible for requesting/submitting all GMP documents to QA.
• During critical campaigns, will support the manufacturing process (shifts)
• Wet lab work will not be more than 10% of your time. 
• Performs other functions as required or assigned.
• Complies with all company policies and standards.