About this role
Description:
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.
Essential Functions:
- Execute the production schedule as planned, ensuring equipment/material availability prior to executing the days production. Perform all required tasks with minimal supervision.
- Responsible for 100% documentation accuracy on all GMP documents, such as bath records, log books, training records, in-process forms.
- 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.
- 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.
- The 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.
- Work closely with Technical Writer in generating detailed equipment SOP’s, focusing on set-up, operation, and cleaning
Additional Responsibilities:
- 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
Education:
- High School or GED - Required
Experience:
- 1 year or more in pharmaceutical manufacturing environment, particularly with operating cream/ointment/lotion processing equipment
Specialized Knowledge:
- 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• Must have good verbal communication skills in English
- Must posses analytical problem solving and trouble shooting skills.
- Lean six Sigma experience a major plus
- Must have the ability to interact with individuals from all levels throughout the organization
- Must be a motivated self starter, requiring little to no supervision to accomplish their daily tasks
- Must have the ability to generate reports/response to investigations
- Must have excellent attention to detail.
- Must be an excellent “team” player – assisting co-workers when necessary, and providing training and guidance as needed, particularly to new operators.
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. 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.