• Quality Control Analyst II

    System One (Piscataway, NJ)


    Job Title: QC Analyst II

     

    Hours/Schedule: M-F, 8:30 am – 5:00 pm (May require extended hours or weekends during manufacturing runs)

    Overview

    We are seeking a QC Analyst II with a strong background in small molecule and protein chemistry to support our client’s QC laboratory in a cGMP-compliant environment. The role involves analytical testing and data verification to support both late-stage clinical and commercial products, including biosimilars. The ideal candidate will be skilled in troubleshooting analytical results and working with cross-functional teams on projects, process improvements, and laboratory investigations.

    Responsibilities

    + Perform analytical testing and data verification to support in-process, release, raw materials, and stability programs.

    + Conduct testing using HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, and ELISA.

    + Collaborate across departments to resolve project issues, conduct lab investigations, and implement process improvements.

    + Document and investigate Out of Specification results, deviations, and implement corrective actions.

    + Support regulatory inspections and prepare dossiers for agency interactions.

    + Maintain laboratory equipment and comply with all company policies, standards, and regulatory guidance.

    Requirements

    + Education:

    + Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 8 years of QC experience in pharma/biotech.

    + OR Master’s degree in the above fields with 6 years of QC experience in pharma/biotech.

    + Experience and Skills:

    + Prior experience in a cGMP laboratory is essential.

    + Strong knowledge in protein and small molecule chemistry and proficiency with techniques such as HPLC, SDS-PAGE, ELISA, and capillary electrophoresis.

    + Experience with SOPs, QC methods, and regulatory dossiers.

    + Demonstrated ability to support regulatory inspections (e.g., PAI).

     

    Working Environment

     

    + Primarily lab-based with some office work for documentation.

    + Must be able to lift 25 lbs.

    + Travel up to 5%-10% as needed.

     

    Benefits

     

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

     

    Ref: #558-Scientific

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.