Transdermal Operator III -Day Shift

Transdermal Operator III

The Transdermal Operator III responsibilities includes equipment start-up, participation in ANDA batch production and commercial batch manufacturing. Primary responsibilities includes training, transdermal mixing, coating, converting, packaging, and cartoning. The Transdermal Operator III is an expert in converting, (die cutting) and will provide support with troubleshooting.

Day Shift – 12-hour per day, rotating schedule (6:00am-6:30pm) 3 days week 1 and 4 days week 2 of pay cycle (Requires every other weekend)

Essential Functions

• Lead other operators during execution of batches and equipment qualifications.
• Execute the production schedule as planned, ensuring equipment/material availability prior to executing the days production.
• Assist Supervisor with resolving issues as they arise.
• Determine root cause and provide solutions.
• Review potential issues/concerns, that may negatively impact the outcome of the successful execution of a batches, to the department Supervisor.
• Monitor line and 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.
• Perform equipment set-up, IQ/OQ/PQ, and commercial batch activities.
• Monitor automatic and semi-automatic equipment to manufacture transdermal products.
• Ensure that all processing equipment, room, scale, and environmental log books are promptly and accurately filled in – recording all activities.
• Work closely with the Technical Writer to generate detailed equipment SOP's, focusing on set-up, operation, and cleaning.
• Continually monitor the actions of the operators in the course of executing the batch record, to ensure compliance.
• Execute commercial validation batches according to SOPs. Ensure 100% documentation accuracy on all GMP documents, such as bath records, log books, training records, in-process forms.
• Operate complex machines and SOPs to complete Transdermal mixing, coating, converting, pouching and cartooning operations.
• Set-up, run and clean equipment in GMP compliant environment.
• Additional Responsibilities
• R&D and commercial scale-up activities scale-up activities.
• Training New Personnel on SOPs and Equipment

Education

• High School or GED
  - Required

Work Experience

• 5 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

Specialized Knowledge

• Thorough understanding of the functionality and operational capabilities of all processing equipment in the Transdermal Department.
• Strong expertise in converting (die cutting) and packaging.

Additional Requirements:

• Successful completion of an OSHA-compliant Respirator Fit Test is required.