Transdermal Operator II - (12 Hrs) 3rd Shift

Role Summary

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.

Responsibilities

• 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.

Qualifications

Education

• High School or GED - Required

Experience

• 3 years of experience in Manufacturing or GMP environment - Required
• 3 years of experience in Pharmaceutical Manufacturing - Preferred

Skills

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

Education

• High School or GED - Required

Additional Requirements

• Flexible to work extended hours when required.
• This position requires successful completion of an OSHA-compliant Respirator Fit Test.