Quality Control (QC) Analyst II

Kashiv BioSciences, LLC • Chicago, IL

1d • Hybrid

About The Position

The Quality Control Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories. This role also involves engaging in continuous improvement initiatives to enhance the efficiency and effectiveness of Kashiv’s Quality Systems. A strong background in protein chemistry is essential for performing and troubleshooting techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. The position requires a demonstrated ability to collaborate across multiple departments to ensure timely resolution of projects, laboratory investigations, and process improvements.

Requirements

• Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 5 years of experience in a pharmaceutical/biotech QC laboratory.
• Alternatively, Master’s degree in above areas with 3 years of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas with a minimum of 2 years of experience.
• Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.

Nice To Haves

• Previous experience in a cGMP laboratory.
• Strong background in protein chemistry and experience troubleshooting analytical results.
• Demonstrated success at writing, revising, and complying with SOPs, protocols/reports, 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.
• 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, and stability programs.
• 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.
• Train other analysts to perform laboratory procedures and assays.
• Participate in internal assessments and audits as and when required.
• Performs other functions as required or assigned.
• Complies with all company policies and standards.

What This Job Offers

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