QC Specialist II

1 week ago


Piscataway, New Jersey, United States Kashiv BioSciences LLC Full time
Job Summary

We are seeking a highly skilled QC Analyst II to join our team at Kashiv BioSciences LLC. As a key member of our quality control team, you will be responsible for analytical testing and data verification to support late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories.

Key Responsibilities
  • Perform analytical testing to support product in-process, release, raw materials, and stability programs.
  • Develop and maintain 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.
  • Collaborate with cross-functional teams to advance projects, maintain equipment, and author documents and reports.
Requirements
  • Bachelor's degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 8 years of experience in a pharmaceutical/biotech QC laboratory.
  • Strong background in small molecule and protein chemistry and experience troubleshooting analytical results.
  • Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods.
Working Environment

This is a full-time position that requires a strong work ethic and ability to work extended hours or weekend hours as needed. The ideal candidate will have a strong background in analytical testing and data verification, with excellent communication and collaboration skills.


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