What are the responsibilities and job description for the Transdermal Operator II - 2nd Shift (8 Hrs) position at Amneal?
Description:
The Transdermal Operator II work function includes equipment start-up, participation in ANDA batch production and commercialbatch 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, or any outside factor that may impact the safety, strength, efficacy of the product.
- 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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Transdermal Operator I - 1st Shift (12 Hrs)
Amneal -
Piscataway, NJ
