Manufacturing QMS Specialist
Kashiv Biosciences LLCNew Jersey, United States
Posted January 19, 2026
Full Time
About the Company
Kashiv Biosciences LLC specializes in biosimilar manufacturing and process equipment support, offering HVAC and BMS maintenance, equipment validation, and intellectual property services for downstream cell culture processes. The company operates in a GMP-compliant environment, providing technical expertise in bioreactor, fermenter, and downstream process equipment maintenance and IP strategy development.
Job Description
Responsible to support manufacturing team with documentation, filing change controls, deviation, CAPA, and author batch records, SOPs, and forms. Attends daily meetings and meets weekly with QA to ensure QMS closure. Supports manufacturing process during critical campaign and performs wet lab work.
Requirements
- Review executed batch records
- File change controls, deviation, CAPA
- Attend daily meetings with upstream and downstream process
- Meet weekly with QA to avoid delay in QMS closure
- Author batch records, SOPs, and associated forms
- Request and submit GMP documents to QA
- Support manufacturing process during critical campaign
- Perform wet lab work (10%)
