• Quality Assurance Specialist II

    Astrix Technology (Plano, TX)


    Quality Assurance Specialist II

     

    Quality Assurance

     

    Plano, TX, US

    Pay Rate Low: 27 | Pay Rate High: 38

    + Added - 04/09/2025

     

    Apply for Job

     

    Our client is a global radiopharmaceutical partner seeking a **Quality Assurance Specialist II** will play a vital role in supporting manufacturing operations by safeguarding the integrity of materials and products, ensuring compliance with regulatory standards, and maintaining quality systems.

     

    Located in Plano, TX

    Contract to hire

    **Pay:** $65k - $80k

    Key Responsibilities

    + Review and inspect documentation for incoming raw materials and packaging components.

    + Conduct detailed reviews of production batch records, logbooks, and associated documentation.

    + Perform area release for manufacturing operations.

    + Support sterile manufacturing processes and provide instruction on sterile gowning and aseptic techniques.

    + Review equipment and instrumentation documentation supporting GMP operations.

    + Scan and archive manufacturing documentation (e.g., batch records, audits, investigations, CAPAs, change controls).

    + Follow up on investigations, CAPAs, and change controls to ensure timely and compliant resolution.

    + Participate in internal audits of GMP and non-GMP processes.

    + Assist in updating Quality SOPs and perform secondary documentation reviews.

    + Support documentation review related to technology transfer from R&D.

    + Flexibility to work varied hours, including early shifts.

    Qualifications:

    + Bachelor’s degree in a scientific or technical discipline.

    + 2–5 years of experience in the pharmaceutical or related industry, with 2–3 years in sterile manufacturing preferred.

    + Strong understanding of GMP and sterile manufacturing practices.

    + Experience writing and revising SOPs.

    + Proficiency in reviewing batch records and quality documentation.

    + Skilled in Microsoft Office Suite.

     

    "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!”

    \#LI-DNP

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    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.