QC Specialist II

2 weeks 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 the development and commercialization of small molecule and biosimilar products.

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.
  • Alternatively, Master's degree in above areas with 6 years of experience in a pharmaceutical/biotech QC laboratory.
Preferred Qualifications
  • Previous experience in a cGMP 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.
Work Environment

This is a full-time position that requires a significant amount of time spent in the laboratory. The ideal candidate will be able to lift at least 25 lbs and work in a high-paced demanding environment to meet ambitious project goals.


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