KB QC Analyst I
About The Position
The Quality Control Analyst I will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories. This role will also be engaged in continuous improvement initiatives to drive efficiency and effectiveness of Kashiv’s Quality Systems. 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 2 years of experience in a pharmaceutical/biotech QC laboratory.
- Alternatively, Master’s degree in above areas with 1 year of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas.
- Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.
Responsibilities
- Analytical testing to support product in-process, release, and stability programs.
- 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.
- A commitment to Kashiv’s Vision, Mission, and Values is essential.
- Performs other functions as required or assigned
- Complies with all company policies and standards
Benefits
- short-term incentive opportunity, such as a bonus or performance-based award
- comprehensive, flexible and competitive benefits program
- above-market, diverse and robust health and insurance benefits
- significant 401(k) matching contribution
- programs that help you enjoy your career alongside life’s many other commitments and opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
