Topicals Operator I - 2nd Shift

Amneal Pharmaceuticals LLC (J0P); Piscataway Township (NJ); On-site; USD 27,000 - 36,000; Full time

Benefits offered by this job

Short-term incentive bonus

Long-term incentive RSUs

Competitive health and retirement plan

Job summary

Amneal Pharmaceuticals LLC is seeking a Manufacturing Operator in New Jersey to set up, operate, and clean topical processing equipment for creams, ointments, and lotions. You will execute batch records, maintain GMP documentation, and follow SOPs and safety procedures to ensure compliant production.

Requirements include 1+ year in pharma manufacturing, High School/GED, and Lean Six Sigma is a plus. The role offers an hourly rate with incentive opportunities.

Qualifications

• 1 year or more in pharmaceutical manufacturing environment.
• Experience operating cream/ointment/lotion processing equipment.
• GMP documentation accuracy is essential.
• Excellent written and verbal communication in English.
• Lean Six Sigma training is a major plus.

Responsibilities

• Execute the production schedule with equipment/materials ready and minimal supervision.
• Maintain 100% accuracy on GMP documents (bath records, log books, forms).
• Keep processing suites and related areas clean and compliant with GMP/SOPs.
• Record all activities in equipment/room/environmental log books promptly and accurately.
• Report issues to the department supervisor that may affect batch success.
• Immediately flag any action that violates cGMPs, procedures, safety, or product integrity.
• Collaborate with Technical Writer to develop detailed equipment SOPs for setup, operation, and cleaning.

Skills

Lean Six Sigma

GMP SOP know-how

English skills

Team player

Self-starter

Education

High School or GED - Required

Job description

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.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail]. Requests will be handled confidentially and in accordance with applicable laws.