• Transdermal Operator II - (12 Hrs) 3rd Shift

    Amneal Pharmaceuticals (Piscataway, NJ)


    Description:

    The Transdermal Operator II (3rd Shift) responsibilities include equipment start-up, participation in ANDA batch production and commercial batch manufacturing. Primary responsibilities include in process checks, operating Transdermal machines.

     

    This role follows a 12-hour rotating schedule, working from 6:00 PM to 6:30 AM.

    Essential Functions:

    + Perform equipment set-up, IQ/OQ/PQ, and commercial batch activities. Monitor automatic and semi-automatic equipment to manufacture transdermal products.

    + Operate complex machines, i.e. Delta, to conduct mixing, coating, converting, pouching and cartoning operations.

    + Set-up, run and clean equipment in a GMP compliant environment.

    + Work with team to troubleshoot and resolve manufacturing issues as they arise.

    + Report issues/concerns or potential issues/concerns, that may negatively impact the outcome of the successful execution of a batch, to the department Supervisor.

    + Immediately notify the department supervisor of any action or activity that is a violation of cGMPs, SOP, or Safety procedures.

    + Ensure that all processing equipment, room, scale, and environmental log books are promptly and accurately filled in – recording all activities.

    + Responsible for 100% documentation accuracy on all GMP documents, such as bath records, log books, training records, in-process forms.

    + Conduct R&D and commercial scale-up activities. cGMP’s, SOP’s, OSHA, regulations are followed at all times during the execution of the batch.

    Additional Responsibilities:

    + R&D and commercial scale-up activities

    + Other duties as assigned.