• QC Analyst II

    Astrix Technology (New Brunswick, NJ)


    QC Analyst II

     

    Laboratory

     

    Middlesex County, NJ, US

    Pay Rate Low: 75000 | Pay Rate High: 80000

    + Added - 07/05/2025

     

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    Position Summary

    The **QC Analyst II** will perform analytical testing and data review in support of late-stage clinical and commercial small molecule and biosimilar products within cGMP-compliant laboratories. This person will effectively perform and troubleshoot a range of techniques, including HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based bioassays.

    Essential Duties & Responsibilities

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

    + Ensure compliance with cGMP regulations, quality systems, and applicable ICH/regulatory guidelines.

    + Participate in the investigation and documentation of Out-of-Specification (OOS) results, deviations, and corrective and preventive action (CAPA) plans.

    + Collaborate across departments to support project advancement, equipment maintenance, and the creation of technical documents and reports.

    + Conduct root cause analyses as part of laboratory investigations and assist in closing quality events.

    + Support regulatory and internal audits as needed.

    + Perform additional duties as assigned.

    + Adhere to all company policies and procedures.

     

    Position Requirements and Qualifications

    Education:

    + Bachelor’s degree in biotechnology, biochemistry, chemistry, or a related field

    + Minimum of **3+ years** of experience

    Experience:

    + Hands-on experience working in a cGMP-compliant laboratory.

    + **Proficient in analytical techniques such as HPLC, SDS-PAGE, ELISA, capillary electrophoresis, and cell-based assays.**

    + Familiarity with preparing regulatory submissions and data packages for interactions with regulatory agencies (e.g., FDA).

     

    This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

    INDBH

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.