What are the responsibilities and job description for the Transdermal Operator II position at Amneal Pharmaceuticals?
Description:
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
Experience:
- 3 years of related experience. Manufacturing or GMP environment
Skills:
- 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
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
