Quality Control (QC) Analyst I, II, & III

Kashiv BioSciences, LLC•Piscataway, NJ

8h•$70,000 - $95,000•Onsite

About The Position

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.

Requirements

A 4-year Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field
Previous experience for QC I (0 to 2 years or more), QC II (2 to 5 years or more), and QC III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
Working knowledge of cGMP regulations (21 CFR210/211/820) is required.
Strong background in small molecule and protein chemistry and experience in troubleshooting analytical results.
Demonstrated success at writing, revising, and complying with SOPs, policies, and QC methods.

Nice To Haves

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.
In-depth understanding and technical knowledge of the analytical methods such as UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA performed under QC laboratory environment, and be familiar with all basic and some complex laboratory equipment/instrumentation.
Strong communication skills, both written and verbal.
Must be detail-oriented.
Must be able to effectively manage time to complete assignments.
Excellent computer skills in Microsoft Office applications

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