• Jt203 - Associate Manufacturing NS

    Quality Consulting Group (Holly Springs, NC)


    QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

    Responsibilities:

    + Completing operations on the floor in Services area and are responsible for the manufacturing of cGMP (current Good Manufacturing Practices) drug substance.

    + Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR] with strict adherence to safety and compliance.

    + Ensure proper gowning and aseptic techniques are always followed

    + Perform hands-on operation including set-up, cleaning, sanitization, monitoring of equipment and assigned area

    + Buffer and Media preparation and transfer

    + Weigh and dispense of materials to be used in the preparation of Buffers and Medias

    + Complete washroom activities: cleaning equipment, small to large scale, use in production activities

    + Run and monitor critical process per assigned procedures

    + Perform documentation for assigned function (i.e., equipment logs, EBRs)

    Qualifications:

    +  High school diploma / GED + 1 year of manufacturing and/or other regulated experience or associate’s degree

    + Completion of NC Bio Works Certificate Program

    + Experience in a regulated industry such as biotechnology or pharmaceutical

    + Basic understanding of GMP principles

    + Strong verbal and written communication skills

    + Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

    + Ability to perform assignments with a high degree of focus/attention to detail.

    + The initial schedule will be Monday-Thursday or Tuesday -Friday, 10-hour days.

    + The schedule will transition to shifts (rotating 2-2-3, 12-hour shifts) upon completion of startup activities and as business needs dictate.

    + 10 candidates for day shift and 10 for night shift needed

     

    Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

     

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