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. 

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.