Topicals Operator I (Manufacturing)

Description:

The Topical Operator I is responsible for the set-up, operation, and cleaning of all process equipment used in the manufacturing of creams, ointments, and lotions. This includes, but is not limited to, the 125L and 1200L Becomix, 100-gallon and 1000-gallon Ross Mixers, 500L Adams Mixer, and other designated processing equipment. The Operator will execute Production Batch Records in accordance with SOPs and cGMP requirements, ensuring accurate documentation and adherence to safety and quality standards throughout all production activities.

Essential Functions:

• Execute the production schedule as planned, ensuring readiness of equipment and materials.
• Perform assigned tasks with minimal supervision, following all applicable SOPs and safety protocols.
• Accurately complete all GMP documentation, including batch records, logbooks, training records, and in-process forms.
• Maintain cleanliness and organization of processing suites, washrooms, hallways, and storage areas in accordance with GMP and SOP standards.
• Ensure all processing, room, scale, and environmental logbooks are completed accurately and promptly.
• Immediately report any deviations, safety concerns, or potential quality issues to the department supervisor.
• Collaborate with the Technical Writing team to develop and update equipment SOPs focused on set-up, operation, and cleaning procedures.

Additional Responsibilities:

• Support other departmental functions as needed, including Packaging and Pharmacy operations.
• Assist in the development of Task Qualification Checklists and participate in training new operators as part of the Certified Trainer Program.

 

Education:

• High School or GED - Required

Experience:

• 1-2 years in pharmaceutical manufacturing environment, particularly with operating cream/ointment/lotion processing equipment
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Skills:

• Familiarity with cream/ointment processing equipment such as Becomix, Ross Mixers, Adams Mixers, and Unimix (Beginner level preferred)
• Basic mechanical aptitude with ability to perform equipment set-up, troubleshooting, and cleaning
• Ability to read, write, and perform basic math calculations in English (Intermediate proficiency)
• Strong attention to detail and documentation accuracy
• Excellent written and verbal communication skills
• Self-motivated and able to work independently with minimal supervision
• Effective team player, willing to assist and train co-workers as needed
• Strong analytical and problem-solving abilities

Specialized Knowledge:

• Prior experience in pharmaceutical operations, including working in a GMP-regulated environment and following SOPs
• Hands-on experience operating pharmaceutical processing equipment (mixers, blenders, processors)
• Lean Six Sigma training or experience preferred
• Able to generate reports and respond to notices of investigation (NOIs)
• Capable of training and mentoring new operators on equipment procedures
• Comfortable working cross-functionally with individuals at all levels of the organization

 

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.