QC Analyst II
Kashiv Biosciences LLCNew Jersey, United States
Posted October 11, 2024
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
The QC Analyst II will be responsible for analytical testing and data verification for small molecule and biosimilar products in cGMP-compliant laboratories. This role requires strong knowledge of protein chemistry and the ability to collaborate effectively across departments to resolve laboratory investigations and process improvements. The position also involves laboratory investigations and adherence to cGMP guidelines.
Requirements
- Analytical testing to support product in-process, release, Raw materials and stability programs.
- Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
- Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
- Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.
