About this role
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.
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.
Other facts
About Amneal
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
What you'll do
- The Transdermal Operator II is responsible for equipment start-up and participating in batch production and commercial manufacturing. This includes operating complex machines and ensuring compliance with GMP standards.
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