Piscataway, NJ, 08854, USA
67 days ago
Transdermal Operator II - (12 Hrs) 3rd Shift
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.
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