Transdermal Operator II - #196619

Amneal Pharmaceuticals


Date: 06/08/2022 07:00 AM

City: Piscataway, New Jersey

Contract type: Full Time

Work schedule: Full Day

Job Summary


The Transdermal Operator II work function includes 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, 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.

Education



  • High School or GED - Required

Work Experience



  • 3 years or more of related experience. Manufacturing or GMP environment - Required

Skills and Abilities



  • Must be able to understand and communicate in English. Must be able to perform repetitive tasks. - Advanced
  • Strong math and mechanical skills. Ability to use computer systems for data entry. - Advanced
  • Flexible to work extended hours when required. - Advanced
  • Ability to work as part of a team. - Advanced
  • Great attention to detail, ability to be accurate and apply good documentation practices. - Advanced

Specialized Knowledge



  • Strong knowledge of converting (die cutting) and packaging

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