Quality Control (QC) Analyst I, II, & III
Company Overview
Creating a Healthier World through Accessible Biologics:
Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC, in the United States, and its subsidiary, Kashiv BioSciences Private Limited, in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.
Position Summary
The Quality Control Analyst 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.
Essential Duties & Responsibilities
- Analytical testing to support product in-process, release, 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 author documents and reports.
- Performs other functions as required or assigned
- Complies with all company policies and standards