• Quality Assurance Specialist

    Astrix Technology (Brownsburg, IN)


    Quality Assurance Specialist

     

    Quality Assurance

    Brownsburg, IN, US

    + Added - 05/09/2025

    Apply for Job

    + **Salary Range** : $62-78K depending on experience

    + **Hours** : 1pm-9:30pm M-F but in 2026 will likely transition to Sun-Thur/4 10's

    Job Description:

    Seeking a GMP QA Specialist to support the Quality oversight of GMP manufacturing and laboratory

    activities. The individual in this role will review documentation

     

    related to raw materials, components, and completed batch records followed by giving a disposition of each. Assist with quality systems improvements.

    Job Duties:

    • Inspect, review documentation, and release incoming raw materials

     

    and packaging components.

     

    • Update Quality SOP’S and perform secondary review of

     

    documentation.

     

    • Perform area release for manufacturing, as needed.

    • Oversee sterile manufacturing process, provide sterile gowning and

     

    practices instruction.

     

    • Review production batch records, logbooks, and associated

     

    documentation to assess completeness, accuracy, and compliance

     

    with SOPs.

     

    • Review of equipment and instrumentation documentation in support of

     

    GMP manufacturing and testing operations.

     

    • Scanning manufacturing documentation such as batch records, raw

     

    materials, audits, investigations, CAPA, and change control.

     

    • Release/disposition GMP products for Macrocyclics and OM.

    • Follow up on investigations, CAPAs and change controls for time

     

    completion.

     

    • Review of documentation related to technology transfer from R&D for

     

    manufacturing activities.

     

    • Perform Internal audits of GMP labs and other non

    • GMP processes as directed.

    Requirements:

    • Associate’s Degree, Bachelor’s Degree preferred

    • 0-3 years experience in Pharmaceuticals or related industry

    • Experience in writing SOPs and other associated GMP

    documentation

    • Proficient in Microsoft Office, Excel, and Power Point

    • Strong written and verbal communication skills.

    • Strong organization skills.

    • Able to easily switch between multiple ongoing projects, adjusting

     

    priorities based on business needs.

    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.