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Transdermal Operator II - (12 Hrs) 3rd Shift at Amneal India
Piscataway, New Jersey, United States -
Full Time

Start Date

Immediate

Expiry Date

21 Feb, 26

Salary

0.0

Posted On

23 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Equipment Set-Up, GMP Compliance, Transdermal Machines, Batch Production, Troubleshooting, Documentation Accuracy, Mixing, Coating, Converting, Pouching, Cartoning, cGMP, SOP, OSHA Regulations, R&D Activities, Commercial Scale-Up

Industry

Pharmaceutical Manufacturing

Description
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.
Responsibilities
The Transdermal Operator II is responsible for equipment start-up and participating in ANDA batch production and commercial batch manufacturing. This includes operating Transdermal machines and conducting in-process checks.