Topicals Operator I - 2nd Shift

About the role

The Manufacturing Operator performs the set-up, operation, and cleaning of pharmaceutical processing equipment used in the manufacture of topical products, including creams, ointments, and lotions. The role is responsible for executing batch records, maintaining accurate GMP documentation, and following all applicable SOPs, cGMP requirements, and safety procedures to support safe, compliant, and efficient production.

Responsibilities

• Execute the production schedule as planned, ensuring equipment/material availability prior to executing the day's production
• Perform all required tasks with minimal supervision
• Responsible for 100% documentation accuracy on all GMP documents, such as batch records, log books, training records, in-process forms
• Responsible for overall appearance of the processing suites, ensuring all suites, hallways, washroom, and storage areas are clean and well kempt as per GMP guidelines and SOP procedures
• Ensure that all processing equipment, room, scale, and environmental log books are promptly and accurately filled in – recording all activities
• 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
• Immediately notify the department supervisor if observing 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
• Work closely with Technical Writer in generating detailed equipment SOPs, focusing on set-up, operation, and cleaning
• Secondary role, when not needed in Manufacturing, is to support other department activities, such as Packaging, and Pharmacy
• Participate in the generation of “Task Qualification Checklists” for the Certified Trainer Program, and train new operators as required

Requirements

• High School or GED – Required
• 1 year or more in pharmaceutical manufacturing environment, particularly with operating cream/ointment/lotion processing equipment

Skills

• Previous pharmaceutical operations experience
• GMP & SOP familiarity
• Previous experience operating pharmaceutical processing equipment, particularly packaging equipment
• Lean Six Sigma training/experience a major plus
• Excellent written skills
• Good verbal communication skills in English
• Analytical problem solving and troubleshooting skills
• Ability to interact with individuals from all levels throughout the organization
• Motivated self-starter, requiring little to no supervision to accomplish daily tasks
• Ability to generate reports/response to investigations
• Excellent attention to detail
• Excellent team player – assisting co-workers when necessary, and providing training and guidance as needed, particularly to new operators

Pay

The hourly rate for this position ranges from $19.50 – $26.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months.

Benefits

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.