Amneal Pharmaceuticals LLC (J0P) Transdermal Operator III - 3rd Shift in Piscataway, New Jersey
The Transdermal Operator III work function includes equipment start-up, participation in ANDA batch production and commercial batch manufacturing. Primary responsibilities includes training, transdermal mixing, coating, converting, packaging, and cartoning. The Transdermal Operator III is an expert in converting, (die cutting) and will provide support with troubleshooting.
Lead other operators during execution of batches and equipment qualifications. Execute the production schedule as planned, ensuring equipment/material availability prior to executing the days production.
Assist Supervisor with resolving issues as they arise. Determine rootcause and provide solutinos. Review potential issues/concerns, that may negatively impact the outcome of the successful execution of a batches, to the department Supervisor. Monitor line and notify the department supervisor of any action or activity that is a violation of cGMPs, SOP, or Safety, or any outside factor that may impact the safety, strength, efficacy of the product.
Perform equipment set-up, IQ/OQ/PQ, and commercial batch activities. Monitor automatic and semi-automatic equipment to manufacture transdermal products.
Ensure that all processing equipment, room, scale, and environmental log books are promptly and accurately filled in recording all activities. Work closely with the Technical Writer to generate detailed equipment SOPs, focusing on set-up, operation, and cleaning. Continually monitor the actions of the operators in the course of executing the batch record, to ensure compliance.
Execute commercial validation batches according to SOPs. Ensure 100% documentation accuracy on all GMP documents, such as bath records, log books, training records, in-process forms.
Operate complex machines and SOPs to complete Transdermal mixing, coating, converting, pouching and cartoning operations.
Set-up, run and clean equipment in GMP compliant environment.
R&D and commercial scale-up activities scale-up activities.
Training New Personnel on SOPs and Equipment.
Equal Opportunity Employer-minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity