Job Description

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.