What are the responsibilities and job description for the QC Analyst II position at Kashiv BioSciences LLC?
Job Type
Full-time
Description
Position Summary
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.
Essential Duties & 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.
Requirements
Position Requirements and Qualifications
Education :
Experience :
Specialized Knowledge and Skills :
Work Environment & Physical Demands :
General Working Environment :
Noise :
Standing / Lifting :
Visual :
Stress :
Travel :
Supervisory Responsibility, if any : No
This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
