Topicals Operator III -2nd Shift

Description:

Topical Operator III is responsible for the set-up, operation, and cleaning of pharmaceutical processing equipment used in the manufacture of creams, ointments, and lotions, ensuring compliance with cGMP standards and SOPs. This role requires strong mechanical aptitude, attention to detail, and the ability to work independently while supporting team training and production goals.

Essential Functions:

• Responsible for having a full and thorough understanding of the functionality and operational capabilities of all processing equipment in the Topicals Department, executing the production schedule as planned, ensuring equipment/material availability prior to executing the days production. Perform all required tasks with minimal supervision, acquainted with all equipment related SOP’s, from set-up, cleaning, and operation. Continually monitor the actions of the operators in the course of executing the batch record, to ensure compliance.
• Responsible for 100% documentation accuracy on all GMP documents, such as bath records, log books, training records, in-process forms ensure that all processing equipment, room, scale, and environmental log books are promptly and accurately filled in – recording all activities.
• Responsible for overall appearance of the processing suites, ensuring all suites, hallways, washroom, and storage areas a re clean and well kempt as per GMP guidelines and SOP procedures
• Work closely with Technical Writer in generating detailed equipment SOP’s, focusing on set-up, operation, and cleaning
Responsible for reporting to the department supervisor any issue/concern, or potential issue/concern that may negatively impact the outcome of the successful execution of a batch. The Sr Operator will immediately notify the department supervisor if he/she observes any action or activity that is a violation of cGMPs, Procedures, or Safety, or any outside factor that may impact the safety, strength, efficacy of the product

Additional Responsibilities:

• Participate in the “Certified Trainer Program” when implemented. Requirements include, generating a “Task Qualification Checklist”, completing a “Train the Trainer” program, working closely with the Technical Writer in generating new and detailed SOP’s, training new operators on all processing equipment, and evaluating said performance
• Support other department activities, such as Packaging, Pharmacy, training of other employees, etc
• Participate in the generation of “Task Qualification Checklists” for the Certified Trainer Program, and train new operators as required
• Work all necessary overtime, as directed by the department Supervisor, whether it be on a daily basis, or over the weekend in order to execute the production plan and meet customer delivery demand.

Experience:

• 5 years in pharmaceutical manufacturing environment, particularly with operating cream/ointment/lotion processing equipment or related field

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

The hourly rate for this position ranges from $24.00 to $32.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

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.