Manufacturing QMS Specialist

About the role

Full-time exempt position at Kashiv BioSciences, LLC located in Chicago, IL. Under the direction of Manufacturing Management, the Manufacturing QMS Specialist will execute routine documentation work including writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPAs, etc. This role requires technical expertise in upstream and downstream biologics manufacturing (cytokines, monoclonal antibodies). Work environment includes no extraordinary noise levels, standing/lifting, or visual requirements; a high‑paced demanding environment to meet ambitious project goals; travel is generally none, though some travel may be involved.

Responsibilities

• Support manufacturing team with all kinds of documentation.
• Review executed batch records (upstream and downstream).
• File change controls, deviations, and CAPAs for the manufacturing department.
• Use investigation tools (5Why or 6M method) for critical/major investigations.
• Attend daily meetings with upstream and downstream processes to capture documentation requirements.
• Meet weekly with QA to avoid delays in QMS closure.
• Author batch records, SOPs, and associated forms/formats for manufacturing processes.
• Request/submit all GMP documents to QA.
• Support manufacturing process during critical campaigns (rotating shifts).
• Limit wet lab work to no more than 10% of time.
• Perform other functions as required or assigned.
• Comply with all company policies and standards.

Requirements