QC Analyst II

Kashiv BioSciences, LLC • Piscataway, NJ

1d • Onsite

About The Position

The QC Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required.

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.
• 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.
• Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.
• Knowledge of and experience with Empower and/or Shimadzu software
• Previous experience supporting regulatory inspections (e.g. PAI).
• Familiarity with preparing regulatory dossiers and data packages for interactions between Kashiv and regulatory agencies.

Responsibilities

• 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.
• Performs other functions as required or assigned
• Complies with all company policies and standards
• Perform the investigation analysis during the non-conformance.
• Conduct the investigation process as a part of Quality Event and work with supervisor to close the investigation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level