• QA Specialist II

    Astrix Technology (Dallas, TX)


    QA Specialist II

     

    Quality Control

     

    Dallas, TX, US

    Pay Rate Low: 24 | Pay Rate High: 28

    + Added - 25/08/2025

     

    Apply for Job

     

    _Rapidly growing Biotech Manufacturer is seeking a QA Specialist II_ _near Dallas, TX! This is a great opportunity to work with an innovative company that has cutting-edge technology!_

    QA Specialist II

    **Terms** : C2H 6mo conversion

    **Pay** : $24-$28/hr DOE

    **Schedule** : Variable - start times could vary

     

    QA Specialist II – Sterile Manufacturing

     

    Step into a key quality role that keeps life-saving products safe and compliant. As a **QA Specialist II** , you'll be the quality gatekeeper for GMP manufacturing—reviewing critical documentation, inspecting materials, and ensuring every step meets strict regulatory standards. Your focus: supporting sterile operations, driving compliance, and fueling continuous improvement.

    What You’ll Do:

    + Review batch records, raw materials, and packaging docs for compliance

    + Oversee sterile manufacturing areas, including gowning and aseptic technique guidance

    + Perform area releases and inspect GMP equipment/instrumentation documentation

    + Track and close investigations, CAPAs, and change controls

    + Archive essential QA documents and support tech transfer from R&D

    + Help update SOPs and conduct internal audits

    What You Bring:

    + Bachelor’s in a scientific/technical field

    + 2–5 years in pharma or related industry, with 2+ in sterile manufacturing preferred

    + Strong GMP knowledge and experience reviewing batch records

    + Skilled in SOP writing and document systems

    + Hands-on experience with aseptic training, internal audits, and tech transfer

    + Familiarity with CAPA, change control, and eQMS toolsThis 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:\#LI-DNP:

     

    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.