• QC Analyst III

    Astrix Technology (New Brunswick, NJ)


    QC Analyst III

     

    Laboratory

    Middlesex County, NJ, US

    + Added - 25/07/2025

     

    Apply for Job

    Direct Hire Opportunity: $70,000 - $80,000

    Exciting opportunity for an experienced QC Analyst to advance their career with a global biopharmaceutical leader! Join a company with a strong international presence in both R&D and manufacturing, and play a key role in delivering innovative therapies to patients worldwide.

    Position Summary

    The QC Analyst III will conduct and review analytical testing to support late-stage clinical development and commercial manufacturing of small molecule and biosimilar products in a cGMP-regulated laboratory setting. This role requires a detail-oriented professional with strong technical proficiency and troubleshooting skills across a range of analytical methods, ensuring data integrity and compliance with regulatory requirements.

    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 **6+ 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

    \#LIDNP

    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.