QC Analyst III
Kashiv Biosciences LLCNew Jersey, United States
Posted October 22, 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
This QC Analyst III role is responsible for analytical testing and data review for late-stage clinical and commercial small molecule and biosimilar products in cGMP laboratories. The role requires a strong background in protein chemistry and experience troubleshooting various analytical techniques, and collaboration across multiple departments. The ideal candidate will be capable of preparing protocols and reports for projects and meeting cGMP guidelines.
Requirements
- Analytical testing to support product in-process, release, and stability programs.
- Perform the data verification/Review process as assigned.
- Participate in Method Validation activity.
- Preparation of the Protocols/Reports as assigned.
- 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.
